Director, Regulatory Affairs CMC, Intercontinental - United Kingdom
- Our company is one of the world’s largest independent biotechnology companies, with global revenue in excess of $18 billion and over 18,000 employees globally.
- For more than 35 years, our company has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient.
- Our company has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.
- Strategic Regulatory Affairs CMC partner for key stakeholders in Global Regulatory Affairs and Safety (GRAAS) (Therapy Areas and Affiliates) and in Operations (Global & Int’l Operations, Global & Int’l Quality, Alliance Management & manufacturing sites) for CMC & GMP issues related to defined regions (CEE, MEA, LA and AP)
- Strategic partner for Global RA CMC Product teams in ensuring product development and supply chain strategies are aligned with regulatory/GMP requirements and limitations in defined regions
- Strategic RA CMC partner for GRAAS Affiliates & Operations / Quality for the integration of manufacturing sites in defined regions into the company network
- Establishment of appropriate RA CMC infrastructure (processes, templates, intelligence & policy databases) to enable successful regulatory approvals in defined regions
- Establishment of appropriate cross-functional processes, policies & standards to enable successful launch and supply continuity in defined regions
- Develop & leverage RA expertise in both CMC and Regional requirements to guide successful product development strategies & supply chain continuity
- Advising Global Product Teams on regional RA CMC requirements influencing product strategy
- Facilitating key regional decisions which impact global product development and filing strategies
- Providing recommendations regarding regional strategy to GRAAS (e.g. GRRC, GCRB) and Operations Senior Management (e.g. OGC) for endorsement
- Representing RA CMC at GRAAS (e.g. GEMST) and cross-functional governance forums
- Bachelor’s degree in related discipline
- In depth experience of pharmaceutical/biotechnology or medical device industry
- Broad experience of Regulatory Affairs
Regional language skills
- Specific expert experience in one or more of the defined Regions including Latin America, Canada, Middle East and Africa
- Broad experience in Emerging Markets regulatory affairs, supporting complex submissions for both biotechnology and chemically-derived products.