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Regulatory Affairs Manager Oncology contract

Hays Careers
Uxbridge
3 weeks ago
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Regulatory Affairs Manager, oncology, contract job, hybrid working, long term contract
Are you an experienced Regulatory Affairs professional with a strong background in oncology? We're currently supporting a leading global biopharmaceutical company in their search for a Regulatory Affairs Manager to join their team on an 18-month contract. This role is critical to the success of ongoing clinical trials across lung, genitourinary (GU), and gastrointestinal (GI) cancers, as well as supporting marketing applications.
Key Responsibilities:

  • Act as the Regional Regulatory Lead for assigned oncology products and indications.
  • Lead Regulatory Submission Teams, representing the regulatory function in cross-functional project groups.
  • Drive the preparation and timely submission of regulatory documentation including INDs, amendments, DSURs, IB updates, and briefing packages.
  • Provide strategic input into labelling content and ensure packaging and product information aligns with regulatory requirements.
  • Review and author regulatory documents, ensuring quality and compliance.
  • Identify regulatory risks and develop mitigation strategies.
  • Contribute to process improvements and special projects within the regulatory department.
  • Mentor and guide junior team members; may include line management responsibilities.


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