INTERNATIONAL Regulatory Affairs Contract-Senior manager / AD
| Posting date: | 27 May 2025 |
|---|---|
| Salary: | £90.0 to £105.0 per hour |
| Additional salary information: | Umbrella Rate up to £100 per hour |
| Hours: | Full time |
| Closing date: | 03 June 2025 |
| Location: | Milton Keynes, Buckinghamshire, MK1 1AS |
| Company: | Hays Specialist Recruitment |
| Job type: | Contract |
| Job reference: | 4691153_1748360957 |
Summary
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.