Regulatory Affairs Manager Oncology contract

Job 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 fo...