We are seeking a Regulatory Affairs Contractor at Manager or Sr Manager level to support global regulatory activities across oncology programmes. This role requires a hands-on professional with strong experience in clinical trial submissions via CTIS and a solid understanding of EU regulatory frameworks. Experience with Marketing Authorisation Applications (MAA) is highly desirable.
Key Responsibilities
- Prepare, review, and submit Clinical Trial Applications (CTAs) through the Clinical Trials Information System (CTIS).
- Act as a subject matter expert for CTIS processes, ensuring compliance with EU Clinical Trial Regulation (CTR).
- Contribute to or lead preparation of MAA dossiers (Module 1–5) where applicable.
- Ensure all submissions meet regulatory requirements, timelines, and internal quality standards.
- Track regulatory milestones and maintain submission documentation.
Required Experience
- Experience in Regulatory Affairs within the pharmaceutical or biotech industry.
- Proven hands-on experience with CTIS submissions is essential.
- Experience working on oncology development programmes
- Ability to independently manage submissions and regulatory activities in a fast-paced environment.
- Experience with Marketing Authorisation Applications (MAA), including dossier preparation and submission is desirable
- Familiarity with global regulatory environments beyond the EU is a plus.