Regulatory Affairs Manager

Freyr Solutions
Bristol
2 months ago
Applications closed

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About Freyr

Freyr 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 Manager

Location: Remote ( United Kingdom )

Job Type: Permanent/Full-Time

Key Responsibilities

  • Provide 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 Competencies

  • Overall 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.

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Why Join Freyr

Joining 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.t.


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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