This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities
Job Summary
This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities.
You will also be responsible for the timely delivery of clinical trial approvals and maintaining high regulatory compliance standards for the UK through the provision of local regulatory expertise.
At AstraZeneca's Biopharmaceuticals Business Unit, we are at the forefront of medical leadership across our enterprise and the healthcare ecosystem.
Matching Summary
This role involves delivering and maintaining competitive licenses for the UK, driving regulatory strategy for new initiatives, and ensuring regulatory compliance for defined product and project responsibilities.
Salary
Competitive Salary & Benefits
Skills & Requirements
Must-have
Regulatory Affairs Lead
UK regulatory expertise
MHRA requirements knowledge
Life Sciences Degree
Line management experience
Operational regulatory experience
Nice-to-have
Therapy Area Expertise
Orphan drug applications experience
Paediatric indications experience
New MAAs experience
New indications experience
Clinical trial submissions experience
Key Requirements
Life Sciences Degree or professional qualifications
Significant UK-based Global Pharmaceutical Regulatory Affairs experience
Line management or project team leadership experience