Director Regulatory Science CMC at Oxford Biomedica, Apply Now!
Are you an expert in CMC regulatory affairs for biological and advanced therapy medicinal products? Oxford Biomedica (OXB) is seeking a Director of Regulatory Science – CMC to lead global regulatory strategies and ensure compliance for gene therapy products in clinical and commercial stages. Based in Oxford, UK with flexible remote options, this is a rare opportunity to join a pioneering viral vector CDMO supporting the world’s most innovative gene therapy developers.
Location: Oxford, GB
Company: oxfordbiom
About Oxford Biomedica
We use science to save lives, and so can you.
Job Description
We are currently recruiting for a Director, Regulatory Science CMC team. The purpose of this role is to develop and execute worldwide regulatory CMC strategies with our clients and to ensure regulatory CMC compliance for clinical development and commercial gene therapy products. We are happy to consider flexible home working arrangements combined with some on-site presence.
Responsibilities
- Act as key CMC regulatory contact and interface with external and internal clients and with global regulatory bodies.
- Propose and develop regulatory strategies with internal and external clients to meet pre-defined development milestones and goals.
- Write, review and manage CMC regulatory documentation for filing to regulatory agencies.
- Coordinate and author CMC/quality responses to questions from regulatory agencies and external clients.
- Provide regulatory CMC input and direction into Agency communications.
- Provide regulatory review and sign off for technical change control and deviations in a timely manner.
- Support regulatory intelligence activities to ensure ongoing regulatory compliance.
Requirements
- Bachelor’s degree in a life science
- CMC specific regulatory experience in the areas of biological and/or advanced therapy products
- Direct experience with EU and US regulatory procedures
- Good understanding of GMP regulations
- Comprehensive knowledge of regulatory guidelines affecting the quality, manufacturing, and controls of biological and advanced therapy products
- Client-centric with proven ability to work to tight deadlines and balance multiple projects
Benefits
- Highly competitive total reward packages
- Wellbeing programmes
- Development opportunities
- Welcoming, friendly, supportive colleagues
- A diverse and inclusive working environment
- State-of-the-art laboratory and manufacturing facilities
Keywords: Director Regulatory, CMC, Oxford Biomedica, Regulatory Science
