Regulatory Affairs Specialist

Regulatory Affairs Specialist (UK Market) – Remote (Part-Time or Full-Time)

Contract Type: 12-month contract (possibility of extension)

Workload: Part-time (20h/week) or Full-time

Location: Remote (within Europe)

Start Date: ASAP

About the Role

We are seeking an experienced Regulatory Affairs Manager with strong UK market experience to support ongoing regulatory activities across the UK and EU region. The ideal candidate will have hands-on experience managing regulatory submissions, renewals, and variations, as well as direct interaction with UK local health authorities.

Key Responsibilities

• Manage and update country-specific regulatory documents (SmPC, PIL, PI, and label deviations).
• Oversee regulatory submissions, renewals, and variations (MRP/DCP, PSURs) in compliance with UK and EU requirements.
• Provide regulatory support for MAAs and maintain up-to-date regulatory intelligence for the UK market.
• Act as the main point of contact for internal stakeholders, third parties, and UK local health authorities.
• Review SOPs, translations, and artworks to ensure alignment with global CCDS and labeling standards.
• Maintain accurate documentation and contribute to process improvements within the regulatory function.

Requirements

• Proven experience managing a regulatory portfolio for the UK (post-Brexit).
• Strong understanding of UK and EU regulatory frameworks and submission procedures.
• Experience liaising directly with the MHRA and other relevant local authorities.
• Excellent communication skills and ability to work cross-functionally in a global environment.
• Availability for either part-time (20h/week) or full-time engagement.