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.