Regulatory Affairs Manager UK and Ire
| Company: | Hays Specialist Recruitment |
|---|---|
| Salary: | £45 to £55 an hour |
| Hours: | Full-time |
| Location: | Slough, EC2V 6DB |
| Working pattern: | Remote |
| Job type: | Contract |
| Posting date: | 8 Sept 2026 |
| Closing date: | 8 Oct 2026 |
Summary
Regulatory Affairs Manager, UK and Ireland, outside IR35, remote, contract job
Your new company
Our client, a highly regarded Regulatory Affairs consultancy, is seeking an experienced Regulatory Affairs Manager to support a fast-paced and growing generics pharmaceutical company across the UK and Ireland markets.This is an excellent opportunity for a regulatory professional with strong post-approval and life cycle management experience to work within a dynamic environment where regulatory excellence and business agility are key to success.
Your new role
- Lead and manage post-approval regulatory activities across the UK and Ireland portfolios.
- Prepare, review and submit regulatory variations, renewals and other life cycle maintenance activities.
- Coordinate and manage submissions in accordance with MHRA and applicable EMA requirements.
- Ensure regulatory compliance and maintenance of marketing authorisations across multiple products and markets.
- Own regulatory labelling activities, ensuring compliance with UK national requirements and relevant EU guidance.
- Provide regulatory intelligence and strategic advice on evolving UK and Ireland regulatory frameworks.
- Support inspection readiness, governance initiatives and ongoing compliance activities.
- Partner closely with cross-functional teams including Quality, Supply Chain, Medical Affairs and Commercial functions to deliver submissions on time and to a high standard.
- Monitor and assess post-Brexit regulatory developments and their impact on product registrations and life cycle activities.
What you'll need to succeed
We are looking for a regulatory professional who can demonstrate:
- Extensive experience supporting UK and EU regulatory affairs activities, particularly variations, renewals and life cycle management.
- A proven track record of preparing and managing post-approval submissions within generics or branded pharmaceutical environments.
- Strong working knowledge of MHRA procedures and EU regulatory requirements.
- Expertise in regulatory labelling and maintenance of compliant product information.
- In-depth understanding of the evolving post-Brexit UK regulatory landscape, including UK national procedures and EU reliance considerations.
- Experience operating within highly regulated pharmaceutical environments with a strong focus on governance and compliance.
- Excellent stakeholder management skills and experience coordinating cross-functional project teams.
- Strong organisational skills with the ability to manage multiple priorities in a fast-moving environment.
- Regulatory Affairs Manager level experience within the pharmaceutical industry.
What you'll get in return
Remote working, outside IR35
What you need to do now
If you are a Regulatory Affairs professional looking for your next contract opportunity and have a strong background in post-marketing regulatory activities across the UK and EU, we would be delighted to hear from you.
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 us for a confidential discussion about your career.
Related jobs
Head of Contract Management (AWDO-P15135)
Competitive Salary + Benefits
AWD online
RemotePermanentFull timeFinance Manager 2 year FTC remote or hybrid (possibility for further 2 year FTC extension)
£36,000 to £40,000 per year
HIJOBS
Fort William
RemoteContractFull time