Regulatory / Regulatory Affairs Associate Director Global CMC - M4 Corridor

Advanced Regulatory ,
London, Greater London
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Overview

Regulatory / Regulatory Affairs Associate Director Global CMC - M4 Corridor “Due to further planned expansion my client is seeking an Associate Director Regulatory CMC GRL for a for an exciting brand/portfolio leadership role with matrix reporting based in the South-East, M4 Corridor.” My client is a global SME pharmaceutical company with a strong development pipeline and a number of Blockbuster marketed products. Although considered medium in size, their spend on R&D make them competitive at the highest level and sales have continued to rise and rise year on year. With 5 major product launches planned over the next 3-4 years they are hitting impressive levels of growth and achievement. For Regulatory Affairs CMC, they offer roles at EU and Global levels from their global head office based in the South-East/M4 Corridor and have gained a great reputation for giving regulatory professionals real career progression including direct people management. The Role: This is a global regulatory CMC leadership role (covering EU, US, LatAm, MENA, AP, EEU) where you will be responsible for a successful Brand/Portfolio including marketed products and late phase development candidates (small molecules). You will be leading and co-ordinating CMC regulatory and related change control activities for these projects and matrix leading EU and US RA CMC liaisons on Regulatory Sub Teams, Global CMC Development Teams and Regulatory/QA liaison team for marketed products advising on Regulatory CMC issues. The US offices are also on the East Coast, and with the Global HQ in Europe there are no late-evening US calls. Experience need: Ideally you will offer extensive CMC regulatory project management and leadership experience, having working closely with manufacturing sites, R&D and regional regulatory colleagues, with an enthusiastic, positive, and proactive approach, with a determination to succeed. You will have at least 10 years in Regulatory Affairs CMC and have experience of European & International CMC regulatory submissions, requirements and procedures. Remuneration: The package on offer is excellent and includes a full and comprehensive benefits package with full medical coverage for you and your family. The salary, bonus and car allowance are very competitive and you will receive a yearly stock options package. There is great flexibility around home working and time spent in the office, which offers a very nice work-life balance. Location: Based in the M4 Corridor, my client is easily commutable from Maidenhead, Slough, High Wycombe, West London and Oxford. Parking is available. To Apply To apply , please send a full CV to TheoAdvTalent.com , or alternatively, contact Theo Moore on 44 (0)207 801 3384 or Oli Dimitrov on 44 (0)207 801 3388 . We are assigned these roles by our client and will provide you with support throughout the hiring process. About Advanced Search & Our Network Advanced Search , has a network of affiliated companies including ADV Regulatory , and ADV Talent Partners . Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005. Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels. Contact us today to see how we can help you make that next career move on 44 (0)207 801 3380 All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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