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Regulatory Affairs Manager
2 months ago
Hybrid Working - 1-2 days in the Office per week required. Supervision and mentoring of a small team.
Key Responsibilities:- Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues.
- Prepare Regulatory Strategies for new Marketing Authorisation Applications / Post-approval Submissions.
- Be actively involved in due diligence activities including evaluation of Regulatory Strategy and launch timelines, evaluation of risks and Regulatory costs.
Candidates from a Pharma or Generics background in EU Regulatory Registrations and Life-cycle management with over 8 years' experience, and good all-round Regulatory skills should be suitable for this position. You will possess good commercial awareness, a solid understanding of how the business works, and possess an excellent eye for detail.
What We Offer:An excellent salary package awaits the successful candidate including £64,000-£66,000 basic, 20% bonus and leading benefits. Hertfordshire/North of London Location with flexible/hybrid working - 1-2 days in the Office per week required.
