10 months ago
Job title: Regulatory Affairs Manager
A growing Biopharmaceutical business in Oxfordshire, are looking to expand their Regulatory Affairs team. This role will focus on lifecycle activities for a marketed product within Oncology. Future pipeline will lead to pre-approval and clinical development activities.
- Support the preparation, review, and submission of post-approval global regulatory submissions as appropriate, (e.g. variations, meeting requests, briefing packages, annual reports, periodic safety reports).
- Provide in-depth reviews of protocols, reports, presentations, and documents
- Participate in the electronic review and quality verification of regulatory submissions
- Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
- Bachelors or Masters or advanced degree in a scientific discipline
- 5 years of experience in the pharmaceutical and/or biologics industries
- Demonstrated understanding and strategic application of regulations and guidelines for drug development
Salary and benefits:
A competitive salary, car allowance, bonus, pension, healthcare and stock options are on offer
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org