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Regulatory Affairs Specialist

1 month ago

London, Greater London, United Kingdom i-Pharm Consulting Full time
Job Description

We're seeking a highly skilled Regulatory Affairs Manager to support key regulatory activities in oncology clinical trials and marketed products. This role is based in the UK and offers the chance to work with a multinational team and take ownership of regulatory strategies in a global company.

Key Responsibilities:

  • Lead regional regulatory strategies for clinical trials and marketed products in the EU
  • Collaborate with global teams and regulatory agencies to ensure compliance
  • Develop and manage 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 drive agency interactions

Requirements:

  • 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

This is a 12-month contract role offering flexibility with a mix of virtual and occasional onsite meetings. You'll be part of a collaborative and inclusive culture, working on cutting-edge therapies and having a real impact in oncology clinical trials. Gain invaluable experience with a global regulatory leader in the biotech sector.