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Senior) Manager, Regulatory Affairs


Details:
Description:

Senior) Manager, Regulatory Affairs (Consultant)

Location: Maidenhead/Remote (hybrid)
Duration: 12 months initial (FOUR days per week / 0.8 FTE)
Rate: £70-85 per hour (based on experience)

We are working with a leading pharmaceutical company who are seeking an experienced Senior Manager, Regulatory Affairs to shape and drive regulatory strategy across the Europe Area. This high‑impact role will work across development and marketed products, partnering closely with global teams, affiliates and health authorities to ensure successful regulatory outcomes.

Key Responsibilities

Lead the development and implementation of regulatory strategies and risk assessments for assigned products across the Europe Area
Represent regional regulatory requirements within global regulatory project teams to ensure appropriate consideration in global strategy
Collaborate with affiliate Regulatory Affairs teams to guide submissions, health authority interactions and life-cycle management activities
Assess scientific data for regulatory submissions, identify gaps, and develop mitigation strategies to support approvals
Monitor evolving European legislation and lead the development of regulatory responses and policy implementationSkills & Experience Required

Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences discipline
Strong experience in European Regulatory Affairs, including centralised, MRP/DCP and national procedures
Proven track record leading regulatory activities for development products (e.g., scientific advice, PIP)
Effective communicator able to work across complex international and matrixed environments
Strong leadership, organisational skills and ability to work independently with minimal supervisionTo apply:

SRG would be delighted to discuss this opportunity further with you. Please click to apply or contact Theo Charles for more details

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy

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