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(Senior) Manager, Regulatory Affairs
Posted 21 hours 42 minutes ago by Lorien
(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 implementation
Skills & 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 supervision
To 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.
Lorien
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