INTERNATIONAL Regulatory Affairs Contract-Senior manager / AD

Senior Regulatory Affairs Consultant

Location: UK BASED (covering Asia Pacific, Latin America, Central & Eastern Europe)

Company: Global Biopharmaceutical Leader

Your new company

This is an exciting opportunity to join a leading global biopharmaceutical company, renowned for its innovation in neurological and rare disease therapies. You'll be part of a high-performing regulatory team supporting product expansion across 70+ international growth markets.

Your new role

As a Senior Regulatory Affairs Consultant, you will lead regulatory submissions for 1-3 products across Asia Pacific, LATAM, and Central & Eastern Europe. You'll be a key member of the global regulatory project team, collaborating closely with the Global Regulatory Lead (GRL) and cross-functional partners in medical writing, pharmacovigilance, clinical, and CMC.

You'll oversee the operational work of a CRO, ensuring timely and compliant submissions, and play a central role in implementing regional regulatory strategies aligned with EU, US, and Swiss standards. The role also includes lifecycle management (LCM), core data sheet (CDS) compliance, and managing readiness-to-questions (RTQs). Familiarity with Veeva Vault is a plus, as the platform is being introduced.

What you'll need to succeed

• Strong regulatory affairs experience across international markets
• Extensive strategic regulatory experience for LCM products
• Deep understanding of global regulatory frameworks (EU, US, Swiss)
• Experience managing CROs and cross-functional collaboration
• Excellent communication and stakeholder engagement skills
• Proven ability to lead product submissions and lifecycle activities
• Knowledge of Veeva Vault is advantageous.

What you'll get in return

• Opportunity to lead high-impact regulatory projects across diverse global markets
• 12-month contract with scope to extend up to 3 years
• Work with a respected biopharma company on innovative therapies
• Collaborate with global experts in a supportive, cross-functional environment
• Competitive compensation and flexible working arrangements

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact Julia Bowden for a confidential discussion about your career.