12 months ago
Job title: Global Regulatory Affairs Associate Director CMC
A growing Pharmaceutical company in Oxfordshire are seeking a Global CMC Regulatory Affairs Associate Director to join their CMC teams. This role will have the opportunity to work on exciting development and marketed products on a global scale.
- Plan and co-ordinate the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions
- Provide in-depth reviews of protocols, reports, presentations, and documents, anticipating internal and/or external business challenges and/or regulatory issues.
- Interact with cross functional leaders on matters concerning the regulatory affairs business unit
- Coordinate the preparation and timely submission of responses to regulatory agencies
- Minimum of eight years of regulatory CMC, knowledge of biotechnology products, including multi-disciplined experience required
- Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
- Educated to a degree level (Life Science ideally)
Salary and benefits:
A highly competitive annual salary, annual bonus, private healthcare and pension plan is on offer
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org