about 2 months ago
Job title: Regulatory Affairs Project Manager - UK/IE
A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager. This is a UK/IE affiliate role and will work across an Oncology or Immunology portfolio.
- Serves as Health Authority liaison and interfaces with Health Authority
- Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA
- Reviews promotional, non-promotional and training materials, as applicable, and ensure the materials are compliant with local regulations and internal policies and procedures.
- Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information are made in accordance with appropriate timings and requirements and maintain an appropriate tracking of the process as applicable
- 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 Immunology or Oncology would be desirable
Salary and benefits:
A competitive salary, annual bonus, car allowance and further benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org