Job Reference: BBBH23181
Start date: a.s.a.p
We are currently recruiting for an Associate Director Regulatory Affairs to join an International Biopharmaceutical companybased in Oxfordshire and specialising within Oncology and Neurology. This is an exciting time to join a growing company with astrong 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 andcomplex 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 toregulatory 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 regulationsand 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 verbalcommunication skills.
For further details about this role, or other vacancies within Regulatory Affairs, please contact TimBarratt on +44(0)1727 817 626 or email firstname.lastname@example.org
Salary: Â£70000 - Â£85000.00 per annum + share scheme, bonus, car allowance
Salary Benefits: share scheme, bonus, car allowance
Vacancy Type: Permanent
Job Skills: cmc, regulatory affairs, associate director, senior manager, manager, director, biologics, module 3
Contact Name: Tim Barratt
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