Freyr is seeking a Regulatory Affairs Manager to fill a critical role in supporting development and execution of regulatory strategies for clinical trial applications in the EU and UK. This role ensures compliance with clinical trial regulatory requirements and manages submission activities including lifecycle and compliance assessment in alignment with the Global Regulatory Lead (GRL).
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.
Job Title: Regulatory Affairs ManagerLocation: Remote-Based out of EU/UKJob Type: Permanent/Full-TimeExperience : 3 to 5 years.Key Responsibilities
Provide critical support in developing regulatory strategy, planning, and execution of clinical trial application (CTA) submissions in the EU and UK, 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, medical writing,, etc.) and other internal and external stakeholders to contribute to clinical development and global regulatory plans, address regulatory issues, respond to health authority queries, and meet regulatory obligations.
Lead initial and lifecycle CTA submissions, including coordination of Rapid Response Teams and act as a liaison while coordinating CTA activities with multidisciplinary teams and contract research organizations.
Act as liaison to health authorities concerning CTAs.
Research and apply regulatory intelligence and knowledge of strategic options for CTAs to enable innovative regulatory pathways and solutions for complex global requirements and regulatory challenges.
Perform independent QC on prepared CTA submissions, including content review of submission documents and structured data populated within the CTIS and IRAS submission portals.
Provide support for preparation, submission, lifecycle management, tracking 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.
Expert 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.
Proven capability to lead multidisciplinary groups and manage several stakeholders during high pressure and time sensitive activities.
Knowledge of Document Management Systems (Documentum-based preferred).
Recent experience submitting or leading CTA submissions in the EU or UK (both preferred).
Strong computer skills with proven experience in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.
Recent CTA Regulatory application experience in EU or UK (both preferred) is essential.
Ability to lead meetings, deliver presentations and comfortably collaborate with international stakeholders in English
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.
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