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Regulatory Affairs Manager

2 months ago

London Area, United Kingdom i-Pharm Consulting Full time

Exciting Opportunity: Regulatory Affairs Manager (12-Month Contract)


We’re looking for a Regulatory Affairs Manager to join our dynamic global team and support key regulatory activities in oncology clinical trials and marketed products. This is a 12-month contract role based in the UK, offering the chance to work with a multinational team and take ownership of regulatory strategies in a global company.


What You’ll Do:

  • Lead regional regulatory strategies for clinical trials and marketed products in the EU
  • Collaborate with global teams and regulatory agencies to ensure compliance
  • Play a key role in developing and managing submissions, labelling, and product life cycles
  • Provide insights to the Global Regulatory Team (GRT) and Global Development Team (GDT) on regional regulatory requirements
  • Support or manage a regional team and help drive agency interactions


What We’re Looking For:

  • 5+ years of independent experience in regulatory affairs, supporting Clinical Trials (preferably in oncology)
  • Strong knowledge of EU regulations and experience with CTAs, MAs, and regulatory submissions
  • Exposure to marketed products – you’ve supported labelling or contributed to regulatory documents like Module 1 of the CTD
  • Experience working in a global environment with cross-functional teams


Be part of a multinational team with a collaborative and inclusive culture - Flexibility with a mix of virtual and occasional onsite meetings - Opportunity to work on cutting-edge therapies and have a real impact in oncology clinical trials - Gain invaluable experience with a global regulatory leader in the biotech sector


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