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Oncology Regulatory Affairs Manager

2 months ago

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

Position: Regulatory Affairs Project Manager – UK/IE

A leading pharmaceutical organization is currently looking for a Regulatory Affairs Project Manager to join their team. This role will focus on an Oncology product line and is based in the UK/IE region.

Key Responsibilities:

  • Act as the primary liaison with Health Authorities, ensuring effective communication and compliance.
  • Oversee the lifecycle management of relevant products and coordinate Clinical Trial activities with regulatory bodies.
  • Evaluate promotional, non-promotional, and training materials to ensure adherence to local regulations and internal guidelines.
  • Manage the submission process for new Marketing Authorisations, variations, and other regulatory documents, ensuring timely and accurate submissions while maintaining comprehensive tracking of all activities.

Qualifications:

  • 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.
  • Proficient in reviewing materials in accordance with the ABPI Code of Practice.
  • Experience in Oncology therapeutic areas is preferred.

Compensation and Benefits:

The organization offers a competitive salary along with an annual bonus and a comprehensive benefits package.