i-Pharm Consulting
Regulatory Affairs Manager
Job Location
Job Description
Exciting Opportunity: Regulatory Affairs Manager (12-Month Contract)
We’re looking for a Regulatory Affairs Manager to join our dynamic global team and support key regulatory activities in oncology clinical trials and marketed products. This is a 12-month contract role based in the UK, offering the chance to work with a multinational team and take ownership of regulatory strategies in a global company.
What You’ll Do:
- Lead regional regulatory strategies for clinical trials and marketed products in the EU
- Collaborate with global teams and regulatory agencies to ensure compliance
- Play a key role in developing and managing submissions, labelling, and product life cycles
- Provide insights to the Global Regulatory Team (GRT) and Global Development Team (GDT) on regional regulatory requirements
- Support or manage a regional team and help drive agency interactions
What We’re Looking For:
- 5+ years of independent experience in regulatory affairs, supporting Clinical Trials (preferably in oncology)
- Strong knowledge of EU regulations and experience with CTAs, MAs, and regulatory submissions
- Exposure to marketed products – you’ve supported labelling or contributed to regulatory documents like Module 1 of the CTD
- Experience working in a global environment with cross-functional teams
Be part of a multinational team with a collaborative and inclusive culture - Flexibility with a mix of virtual and occasional onsite meetings - Opportunity to work on cutting-edge therapies and have a real impact in oncology clinical trials - Gain invaluable experience with a global regulatory leader in the biotech sector
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Location: London, GB
Posted Date: 10/10/2024
Contact Information
Contact | Human Resources i-Pharm Consulting |
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