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Regulatory affairs manager oncology contract

Uxbridge
Regulatory affairs manager
Posted: 11h ago
Offer description

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. In order to be considered for this contract job as Regulatory Affairs Manager in Oncology, you should have a strong Regulatory Affairs background and those with oncology experience would be at an advantage. Why Apply?This is a high-impact role within a globally recognised organisation, offering exposure to cutting-edge oncology trials and regulatory strategy. You'll be joining a collaborative team with a strong track record of innovation and regulatory excellence. The contract is designed to ensure a smooth transition and knowledge handover, with a planned overlap in November.If you're ready to take the next step in your regulatory career and make a meaningful contribution to oncology drug development, we'd love to hear from you.

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