About Freyr. Freyr Life Sciences. is a global leader in regulatory solutions and services within the life sciences industry. Freyr specializes in providing Regulatory Affairs, Pharmacovigilance, and Quality Assurance services. With a diverse team worldwide, we deliver efficient and compliant regulatory solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer healthcare sectors.
Job Title: Assistant Global Labeling LeadLocation: Princeton NJ (Remote)Job Type: Permanent, Full-Time
Position Overview:The Assistant Global Labeling Lead (AGLL) will support Freyr’s Client by assisting the Global Labeling Lead (GLL) in authoring, reviewing, and maintaining key labeling documents such as Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and local labeling across global markets. The role includes coordinating labeling updates, supporting submission activities, ensuring compliance with regulatory requirements, and collaborating with global and regional teams. Strong communication, scientific understanding, and attention to detail are essential for success.
Responsibilities:Assist in authoring, editing, and updating CCDS, USPI, and other labeling documents in alignment with regulatory requirements and internal standards.Review scientific, clinical, and regulatory information to support high-quality labeling content.Collaborate with the GLL to ensure consistency between global labeling and regional/local market requirements.Coordinate labeling updates across global markets and maintain accurate version control.Support preparation of labeling submission packages for regulatory authorities.Ensure labeling documents align with overall regulatory and commercial strategies.Address labeling-related questions from affiliates and regulatory authorities.Maintain accurate documentation and ensure compliance with internal SOPs and industry regulations.Work closely with cross-functional teams with strong communication and collaboration skills.
Minimum Education and Experience:Bachelor’s degree in Pharmacy, Life Sciences, or a related field (preferred).Minimum 5 years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions.Strong understanding of scientific principles and regulatory/quality systems related to drug development.Experience with global labeling standards including CCDS, USPI, and EU SmPC; additional regional labels are a plus.Excellent oral and written communication skills in English.Comfortable presenting to groups of varying sizes.
Knowledge & Other Requirements:Knowledge of global labeling regulations, standards, and processes.Strong attention to detail with the ability to manage multiple tasks and timelines.Ability to collaborate effectively with cross-functional and global teams.Proficiency with regulatory systems and document management platforms.Strong organizational skills and ability to maintain oversight of labeling processes.
Why Join Us? Flexibility: Enjoy remote work with opportunities for client travel and industry engagement.Growth Opportunity: Be part of a fast-growing, global organization at the forefront of life sciences regulatory consulting.Innovation: Work with cross-functional teams delivering cutting-edge solutions to industry leaders.
Equal Opportunity Employer Freyr Life Sciences. is an equal opportunity employer and values diversity at our company. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, or disability status.
About Freyr. Freyr Life Sciences. is a global leader in regulatory solutions and services within the life sciences industry. Freyr specializes in providing Regulatory Affairs, Pharmacovigilance, and Quality Assurance services. With a diverse team worldwide, we deliver efficient and compliant regulatory solutions to clients in the pharmaceutical, biotechnology, medical device, and consumer healthcare sectors.
Job Title: Assistant Global Labeling LeadLocation: Princeton NJ (Remote)Job Type: Permanent, Full-Time
Position Overview:The Assistant Global Labeling Lead (AGLL) will support Freyr’s Client by assisting the Global Labeling Lead (GLL) in authoring, reviewing, and maintaining key labeling documents such as Core Company Data Sheets (CCDS), US Prescribing Information (USPI), and local labeling across global markets. The role includes coordinating labeling updates, supporting submission activities, ensuring compliance with regulatory requirements, and collaborating with global and regional teams. Strong communication, scientific understanding, and attention to detail are essential for success.
Responsibilities:Assist in authoring, editing, and updating CCDS, USPI, and other labeling documents in alignment with regulatory requirements and internal standards.Review scientific, clinical, and regulatory information to support high-quality labeling content.Collaborate with the GLL to ensure consistency between global labeling and regional/local market requirements.Coordinate labeling updates across global markets and maintain accurate version control.Support preparation of labeling submission packages for regulatory authorities.Ensure labeling documents align with overall regulatory and commercial strategies.Address labeling-related questions from affiliates and regulatory authorities.Maintain accurate documentation and ensure compliance with internal SOPs and industry regulations.Work closely with cross-functional teams with strong communication and collaboration skills.
Minimum Education and Experience:Bachelor’s degree in Pharmacy, Life Sciences, or a related field (preferred).Minimum 5 years of experience in pharmaceutical regulatory affairs, labeling, or related scientific functions.Strong understanding of scientific principles and regulatory/quality systems related to drug development.Experience with global labeling standards including CCDS, USPI, and EU SmPC; additional regional labels are a plus.Excellent oral and written communication skills in English.Comfortable presenting to groups of varying sizes.
Knowledge & Other Requirements:Knowledge of global labeling regulations, standards, and processes.Strong attention to detail with the ability to manage multiple tasks and timelines.Ability to collaborate effectively with cross-functional and global teams.Proficiency with regulatory systems and document management platforms.Strong organizational skills and ability to maintain oversight of labeling processes.
Why Join Us? Flexibility: Enjoy remote work with opportunities for client travel and industry engagement.Growth Opportunity: Be part of a fast-growing, global organization at the forefront of life sciences regulatory consulting.Innovation: Work with cross-functional teams delivering cutting-edge solutions to industry leaders.
Equal Opportunity Employer Freyr Life Sciences. is an equal opportunity employer and values diversity at our company. All qualified applicants will receive consideration for employment without regard to race, religion, gender, sexual orientation, national origin, or disability status.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
About FreyrFreyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.
Role Overview:Freyr's client is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of global regulatory strategies for investigational submissions, with a focus on EU and UK CTR. This role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Global Regulatory Lead (GRL).
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of Princeton NJ, USAJob Type: Permanent/Full-Time
Key ResponsibilitiesProvide critical support in developing global regulatory strategy, planning, and execution of global investigational submissions, and manage lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).Work collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to contribute to global regulatory plans, address global regulatory issues, respond to health authority queries, and meet regulatory obligations.Research and apply regulatory intelligence and knowledge of strategic options to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.Perform independent QC on prepared CTA submissions, including submission documents and structured data populated within the CTIS and IRAS submission portals.Act as a liaison while coordinating CTA activities with multidisciplinary teams.Provide support for preparation, submission, lifecycle management, and archival of CTA submissions and related correspondence.Assist with the development of assigned regulatory operations work instructions.Stay current with updates to regulatory and industry standards.
Required CompetenciesOverall knowledge of regulations/guidance supporting EU Clinical Trial Regulation (CTR) and UK The Medicines for Human Use (CTs) (Amendment) (EU Exit) Regulations 2019 (to be replaced by new Clinical Trials Regulations in April 2026).Demonstrated performance in managing and producing time-intensive deliverables.Strong attention to detail in data entry accuracy and in following specific process steps outlined in procedural documents.Knowledge of Document Management Systems (Documentum-based preferred).Recent experience submitting regulatory submissions using Health Authority Portals.Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.Recent CTA Regulatory application experience is essential.
Why Join FreyrJoining Freyr gives you the platform to work on impactful regulatory initiatives across global markets. You will collaborate with experienced regulatory leaders, gain exposure to complex submissions, and contribute to meaningful projects supporting patient safety and global transparency.
What we Offer:Opportunity to work within a collaborative and growth-driven global regulatory team, cross-functionally supporting innovative clinical trials.Lead complex CTA submissions while shaping regulatory strategies aligned with EMA, MHRA, and ICH guidelines.
