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Regulatory Affairs Manager

3 months ago

London, Greater London, United Kingdom Turner Regulatory Full time
Principal Regulatory Officer / EU; Pharma & Generic Products / Project Manager

Turner Regulatory is seeking a highly skilled Principal Regulatory Officer to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.

Key Responsibilities:
  • Liaise closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure regulatory compliance.
  • 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.
Requirements:
  • Candidates from a Pharma or Generics background in EU Regulatory Registrations and Life-cycle management with over 8 years' experience.
  • Good all-round Regulatory skills, commercial awareness, and a solid understanding of how the business works.
  • Excellent eye for detail and ability to work in a fast-paced environment.
What We Offer:
  • An excellent salary package 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.