Apsida Life Science are currently partnering with a global biopharmaceutical company recognised for developing innovative medicines that address complex and serious diseases. The organisation combines strong scientific expertise with a patient-first approach, focusing on improving standards of care through breakthrough therapies and close collaboration with healthcare systems.
They are seeking a Senior Regulatory Project Manager to support their UK portfolio.
Location: **M4 Corridor**
As a key member of the Regulatory team, you will act as the primary contact for assigned products, driving regulatory strategy, lifecycle management, and Health Authority interactions, with a strong focus on MHRA engagement.
Responsibilities:
- Act as the primary Regulatory contact for an assigned product portfolio.
- Lead lifecycle management activities, including variations, clinical trials and paediatric investigation plans.
- Develop and execute regulatory strategies and timelines aligned with global and UK objectives.
- Serve as the main liaison with the MHRA, supporting Health Authority interactions and meetings.
- Ensure timely preparation and submission of Marketing Authorisations and other regulatory filings.
- Collaborate cross-functionally with Brand, Affiliate, and Area Regulatory teams.
- Support product launches, acquisitions, and divestitures from a regulatory perspective.
Requirements:
- Degree in Life Sciences or a related field.
- Significant experience within Regulatory Affairs in the pharmaceutical industry.
- Strong understanding of UK regulatory processes and MHRA interactions.
- Experience managing regulatory submissions and lifecycle activities.
- Ability to manage multiple priorities and work both independently and collaboratively.
If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:
Geneva.jones@apsida.com
+44(0)7441341762
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.
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