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.

Responsibilities:

• 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

Requirements:

• 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 matt.thomas@pharma-partners.co.uk