Senior Director, Global Regulatory Affairs CMC - Biologics
Star OUTiCO is recruiting for a unique opportunity as a Senior Director for a client who is a global pharmaceutical company with an exceptional name in many general and specialist medicine therapy areas including Respiratory, Diabetes and Oncology. This organisation has an exceptional product pipeline and several high-profile product launches forecast for the next few years.
The successful candidate will be responsible for leading a team within the Regulatory aspects of Chemistry, Manufacturing and Controls (CMC) for licensed and clinical biological products in development. The primary focus will be on products derived from biotechnology, but also an opportunity to interact with vaccines.
* Leading and managing a Regulatory Affairs team, supporting global objectives and contributing to strategies and planning decisions
* Providing senior strategic leadership and handling Post-Marketing Commitments (PMCs) and Other Regulatory Commitments
* Providing interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations
The ideal candidate will be/have:
* Advanced degree (PhD preferred) with 10/15 years' experience
* Expert knowledge of EMA and FDA regulations
* In-depth knowledge of Biotechnology CMC and some familiarity of vaccines CMC
* Excellent organizational and communication skills
* Demonstrated ability to work successfully on project teams
* RAC certification or equivalent preferred
Apply for this unique opportunity now via the website or contact Jacqueline Watson at the Manchester Office!
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.