Regulatory Affairs Project Manager
4 weeks ago
Job Title: Regulatory Affairs Project Manager - Oncology Portfolio
A leading pharmaceutical company in Berkshire is seeking a Regulatory Affairs Project Manager to join their team. This role will involve working across an Oncology portfolio and will be responsible for ensuring compliance with local regulations and internal policies.
Key Responsibilities:
- Serves as a liaison with Health Authorities and interfaces with them to ensure compliance with regulations.
- Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA.
- Reviews promotional, non-promotional and training materials to ensure compliance with local regulations and internal policies.
- Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions are made in accordance with appropriate timings and requirements.
Requirements:
- Life Sciences Degree or equivalent experience.
- Varied experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledge.
- Experience of reviewing material against the ABPI Code of Practice.
- Therapy experience within Oncology would be desirable.
What We Offer:
A competitive salary, annual bonus and further benefits package is on offer.
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