UK Regulatory Strategy Lead for Medicines

AstraZeneca plc

Greater London

On-site

GBP 70,000 - 110,000

Full time

5 days ago
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Job summary

AstraZeneca plc is seeking an experienced Regulatory Affairs professional to drive and maintain UK licences, shaping regulatory strategy for new initiatives and ensuring compliance across defined projects. The role demands leadership in delivering timely clinical trial approvals and strong collaboration with cross-functional teams to optimise submissions throughout the product lifecycle.

You will act as the regulatory expert for UK activities, guide governance and QMS adherence, manage

Qualifications

  • Experience in regulatory affairs within a UK-based or global pharma company.
  • Post-Brexit UK regulatory experience.
  • Strong stakeholder management and cross-functional collaboration.

Responsibilities

  • Generate Competitive Licences (0-40%).
  • Regulatory Compliance & Governance (0-10%).
  • Commercial Support (0-15%).
  • Formulate and Influence Regulatory Strategy (0-15%).
  • Lead the Organisation and Improve Productivity (0-10%).
  • Clinical Support (0-10%).

Skills

Regulatory affairs
Post-Brexit UK
Cross-functional
Negotiation
IT systems
Lifecycle management
Regulatory science

Education

Life sciences degree

Job description

AstraZeneca plc is seeking an experienced Regulatory Affairs professional to drive and maintain UK licences, shaping regulatory strategy for new initiatives and ensuring compliance across defined projects. The role demands leadership in delivering timely clinical trial approvals and strong collaboration with cross-functional teams to optimise submissions throughout the product lifecycle.

You will act as the regulatory expert for UK activities, guide governance and QMS adherence, manage

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