At a Glance
- Tasks: Lead post-approval regulatory activities and ensure compliance across UK and Ireland.
- Company: Reputable Regulatory Affairs consultancy with a focus on generics pharmaceuticals.
- Benefits: Remote work, competitive pay, and the chance to shape regulatory strategies.
- Other info: Opportunity for career growth in a fast-paced environment.
- Why this job: Join a dynamic team and make a real impact in the pharmaceutical industry.
- Qualifications: Experience in regulatory affairs and strong knowledge of UK and EU regulations.
The predicted salary is between 63000 - 77000 £ per year.
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 deli...
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