Regulatory Affairs Manager
Core
Deliver and maintain competitive licences for the UK, driving regulatory strategy for new initiatives and ensuring regulatory compliance for defined product and project responsibilities.
Role type
Regulatory Affairs Manager
Builds
UK regulatory licenses for AstraZeneca investigational and in-licensed/co-development products
Domain
Life sciences / Pharmaceuticals
Required skills
UK regulatory expertise, Post-Brexit regulatory experience, Lifecycle maintenance of UK Regulatory licenses, Regulatory strategy formulation, Commercial support, Clinical trial support, Negotiation skills, Cross-functional coordination, Audit and inspection knowledge, Drug development knowledge
Preferred skills
Experience with clinical trial applications and IVDs, AI solutions for process improvement, Veeva systems experience, Change management techniques, Disease and therapeutic area expertise
Technologies
Veeva systems, IT systems