Director, Regulatory Affairs Strategy, UK
Description
This individual contributor role at Moderna in London involves shaping and driving the local regulatory strategy for Moderna's mRNA portfolio in the UK and Ireland. The director will lead national regulatory execution, engaging with MHRA and HPRA, to enable rapid access to transformative therapies, ensuring regulatory excellence throughout all phases of development and post-approval. The role focuses on revolutionizing medicine through mRNA technology and making a significant impact on patients' lives worldwide. It is a hands-on opportunity for someone passionate about disruptive innovation in healthcare.
What We're Looking For
Develop and execute a long-term regulatory strategy tailored to the UK and Irish markets, ensuring alignment with global regulatory objectives.,Serve as the primary regulatory contact for MHRA and HPRA across assigned projects and programs.,Manage and deliver multiple complex regulatory submissions, including Marketing Authorisation Applications (MAAs), variations, Clinical Trial Authorisations (CTAs), and Scientific Advice packages.,Drive end-to-end lifecycle activities, including labelling, Paediatric Investigation Plan (PIP) processes, advertising and pre-vetting, and strategic filings for new indications.,Provide strategic regulatory input across clinical, pre-clinical, and commercial programs through all development stages.,Create and maintain regulatory Standard Operating Procedures (SOPs) and working procedures tailored to the UK/Ireland affiliate.,Participate in health authority inspections, and oversee Corrective and Preventive Actions (CAPAs), deviations, and follow-up action plans.,Support clinical trial strategies and submissions within the UK/Ireland, ensuring compliance and optimal timelines.,Engage in industry consultations and pipeline meetings, contributing to policy shaping through commentary on draft legislation.,Actively support the execution of the affiliate's commercial strategy by aligning regulatory efforts with market goals.,Partner cross-functionally with Quality, Pharmacovigilance (PV), Market Access, Supply Chain, Government Affairs, Medical Affairs, and the UK General Manager to drive integrated affiliate success.
Ideal Candidate
10+ years in biotech regulatory affairs with strong leadership skills.,Proactive, agile, and highly experienced.,Advanced experience in interpretation of regulations, guidelines, and policy statements.,Proven ability to work both independently and within project teams, committees, etc. to achieve group goals.,Good knowledge of the VEEVA platform for the authoring and approval of documentation (advantage).
Hard Skills
Soft Skills
Benefits
Special Commitments
May require an enhanced pre-employment check
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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