Overview
The Regulatory Affairs Manager will lead and manage post-approval regulatory activities for a growing generics pharmaceutical company, primarily focused on the UK and Ireland markets. This role involves collaborating with cross-functional teams to ensure regulatory compliance and the maintenance of marketing authorisations, while also providing strategic regulatory advice in a dynamic environment. The ideal candidate will leverage their extensive regulatory experience to navigate post-Brexit challenges, ensuring timely submissions and adherence to both MHRA and EMA regulations.
Responsibilities
- Lead and manage post-approval regulatory activities across UK and Ireland portfolios.
- Prepare, review and submit regulatory variations, renewals, and other life cycle maintenance activities.
- Coordinate submissions in compliance with MHRA and EMA requirements.
- Ensure regulatory compliance and maintain marketing authorisations for multiple products.
- Oversee regulatory labelling activities to comply with UK and EU guidance.
- Provide regulatory intelligence on evolving UK and Ireland regulatory frameworks.
- Support inspection readiness and ongoing compliance initiatives.
- Collaborate with cross-functional teams to deliver timely and high-quality submissions.
Requirements
- Extensive experience in UK and EU regulatory affairs, particularly in variations, renewals, and life cycle management.
- Proven track record of managing post-approval submissions in generics or branded pharmaceutical contexts.
- Strong knowledge of MHRA procedures and EU regulatory requirements.
- Expertise in regulatory labelling and compliant product information maintenance.
- In-depth understanding of the post-Brexit UK regulatory landscape and EU reliance considerations.
- Experience in highly regulated pharmaceutical environments with a focus on governance and compliance.
- Strong organizational skills and ability to manage multiple priorities in fast-paced settings.
- Prior experience at the Regulatory Affairs Manager level within the pharmaceutical industry.