Regulatory Affairs Project Manager
2 days ago
Job Title: Regulatory Affairs Project Manager – UK/IE
A leading pharmaceutical business in the UK is seeking a highly experienced Regulatory Affairs Project Manager to join their team. This role will be responsible for managing clinical trials and regulatory submissions across an Oncology portfolio.
Responsibilities:
- Serve as the liaison with Health Authorities, ensuring compliance with local regulations and internal policies.
- Lifecycle management of products, including submission and content of new Marketing Authorisations, variations, and other regulatory submissions.
- Review promotional, non-promotional, and training materials for compliance with regulations and internal policies.
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.
Salary and Benefits:
We offer a competitive salary range of £60,000-£80,000 per annum, annual bonus, and further benefits package.
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