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(Senior) Manager, Regulatory Affairs

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.