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.

Responsibilities