Global Regulatory Strategy Lead

Parexel International; United Kingdom; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

An established international healthcare consulting firm is seeking an experienced Senior Regulatory Affairs Consultant to drive execution and strategy in gaining market approvals across the UK and Ireland. The ideal candidate will possess over 10 years of experience in the pharmaceutical sector, with significant expertise in regulatory affairs and a deep understanding of the UK market landscape. The role demands strong leadership skills, regulatory intelligence, and the ability to manage multiple projects effectively while providing expert guidance to clients.

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry with substantial experience in Regulatory Affairs.
• Broad background in pharmaceutical business and experience in several areas within regulatory affairs.
• Fluent English, written and spoken.

Responsibilities

• Develop comprehensive international regulatory submission strategies.
• Guide delivery teams in the creation of international dossiers.
• Coach and mentor regulatory teams to ensure objectives are met.

Skills

Leadership in managing regulatory agency negotiations

Strong influencing, negotiation, and relationship management skills

Advanced problem‑solving skills

Education

University degree in a relevant scientific discipline

Tools

Knowledge of CTD format and eCTD submission

Job description

An established international healthcare consulting firm is seeking an experienced Senior Regulatory Affairs Consultant to drive execution and strategy in gaining market approvals across the UK and Ireland. The ideal candidate will possess over 10 years of experience in the pharmaceutical sector, with significant expertise in regulatory affairs and a deep understanding of the UK market landscape. The role demands strong leadership skills, regulatory intelligence, and the ability to manage multiple projects effectively while providing expert guidance to clients.