We are currently recruiting for an Associate Director Regulatory Affairs to join an International Biopharmaceutical company based in Oxfordshire and specialising within Oncology and Neurology. This is an exciting time to join a growing company with a strong portfolio and pipeline of products.
*Planning and co-ordination of the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), as assigned.
*Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products and/or, late, and early stage development programs. Solve unique and complex problems that have a broad impact on the function and/or broader department.
*Regularly interacts with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.
*Coordinate the preparation and timely submission of responses to regulatory agencies. Manage timelines to ensure approvals are timely and development objectives are met.
*Monitor EU and US CMC regulations and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
*Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products.
Required Knowledge and Experience:
*Demonstrated understanding and strategic application of regulations and guidelines for drug development and commercial supply.
*Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
*Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
*Demonstrated understanding of FDA, EMA and ICH guidelines.
*Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
*Demonstrated ability to influence and impact their functional area and department practices
*BSc/BA with a minimum of eight years of regulatory CMC experience.
*English language - written and verbal communication skills.
For further details about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org