UK Regulatory Strategy Manager - Pharma Submissions

AstraZeneca plc; Camden Town; On-site; GBP 70,000 - 110,000; Full time

Job summary

AstraZeneca plc in Pancras Square, London, is seeking an experienced Regulatory Affairs professional to deliver and maintain competitive UK licences, drive regulatory strategy for new initiatives, and ensure compliance with GRP and the local QMS.

You will lead UK submissions, collaborate with cross-functional teams, engage with the MHRA, and support investigational and in-licensed products across the product lifecycle, ensuring timely approvals and robust regulatory governance.

Qualifications

• 4+ years in a regulatory affairs role within a pharma company.
• Post-Brexit UK regulatory experience.
• Ability to lead cross-functional interactions and negotiate effectively.

Responsibilities

• Generate and maintain UK regulatory licences.
• Regulatory governance and compliance delivery.
• Provide regulatory strategy leadership across projects.
• Lead the organisation and improve productivity.
• Support submissions and clinical regulatory activities (e.g., CMC, labeling).
• Coordinate with MHRA and external stakeholders.

Skills

Regulatory affairs

UK regulatory experience

Cross-functional coordination

Negotiation skills

Lifecycle license management

Regulatory strategy

IT systems proficiency

Audit & inspection knowledge

Education

Life sciences degree

Professional qualifications

Tools

Veeva systems

Job description

AstraZeneca plc in Pancras Square, London, is seeking an experienced Regulatory Affairs professional to deliver and maintain competitive UK licences, drive regulatory strategy for new initiatives, and ensure compliance with GRP and the local QMS.

You will lead UK submissions, collaborate with cross-functional teams, engage with the MHRA, and support investigational and in-licensed products across the product lifecycle, ensuring timely approvals and robust regulatory governance.