Regulatory Affairs Program Manager
4 weeks ago
Position: Regulatory Affairs Project Manager – UK/IE
A leading Pharmaceutical organization is currently in search of a Regulatory Affairs Project Manager. This role is part of a UK/IE affiliate and will focus on an Oncology product line.
Key Responsibilities:
- Act as the primary liaison with Health Authorities and engage with them effectively.
- Oversee the lifecycle management of relevant products and coordinate Clinical Trial activities with the MHRA.
- Evaluate promotional, non-promotional, and training materials to ensure compliance with local regulations and internal standards.
- Manage the submission process for new Marketing Authorisations, variations, and other regulatory documents, ensuring that all materials, including labels and local prescribing information, are submitted timely and tracked appropriately.
Qualifications:
- A degree in Life Sciences or equivalent professional experience.
- Diverse experience in Regulatory Affairs, with a solid understanding of commercial affiliate operations and clinical trial processes.
- Proven ability to assess materials against the ABPI Code of Practice.
- Experience in Oncology therapy is preferred.
Compensation and Benefits:
A competitive salary along with an annual bonus and a comprehensive benefits package is available.
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