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...
Regulatory Affairs Manager UK and Ire in Reading employer: Hays
Join a well-established ecological consultancy in Kent that prioritises work-life balance and professional development. With a collaborative team culture and a commitment to delivering high-quality ecological advice, this company offers meaningful career progression opportunities for ecologists. Enjoy flexible working arrangements and the chance to work on diverse projects across the South East and beyond.
