Regulatory Affairs Program Manager

4 weeks ago


Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

Position: Regulatory Affairs Project Manager – UK/IE

A leading Pharmaceutical organization is currently in search of a Regulatory Affairs Project Manager. This role is part of a UK/IE affiliate and will focus on an Oncology product line.

Key Responsibilities:

  • Act as the primary liaison with Health Authorities and engage with them effectively.
  • Oversee the lifecycle management of relevant products and coordinate Clinical Trial activities with the MHRA.
  • Evaluate promotional, non-promotional, and training materials to ensure compliance with local regulations and internal standards.
  • Manage the submission process for new Marketing Authorisations, variations, and other regulatory documents, ensuring that all materials, including labels and local prescribing information, are submitted timely and tracked appropriately.

Qualifications:

  • A degree in Life Sciences or equivalent professional experience.
  • Diverse experience in Regulatory Affairs, with a solid understanding of commercial affiliate operations and clinical trial processes.
  • Proven ability to assess materials against the ABPI Code of Practice.
  • Experience in Oncology therapy is preferred.

Compensation and Benefits:

A competitive salary along with an annual bonus and a comprehensive benefits package is available.



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