Regulatory Specialist

Are you an experienced professional in regulatory affairs looking for a pivotal role to influence compliance strategies for international markets? Do you possess a strong background in regulatory frameworks and an aptitude for managing complex interactions with health authorities? If you are a collaborative professional ready to take ownership of the UK and Swiss Responsible Person functions, this role offers an opportunity to make a significant impact.

Job Title - Regulatory Specialist - UK & Swiss

Job Location - Dundee (Full-time, office-based)

Job Type - 12 months (potential for extension)

Pay rate - £45,000 per annum

Job Summary

The incumbent will manage regulatory activities as the UK and Swiss Responsible Person for all sites outside Dundee/CMI. Responsibilities include overseeing vigilance, regulatory intelligence, change assessments, and direct interfacing with the MHRA and Swissmedic. You will lead product inclusion activities for UK and Swiss markets, ensuring all products meet stringent regulatory compliance standards. Additionally, you will act as the site lead for assessing changes in regulatory requirements and quality standards, implementing impact assessments, and managing technical documentation on behalf of legal manufacturers.

Qualification/education

Experience

Professional background in compliance or regulatory affairs. Candidates with strong regulatory experience may be trained specifically for the UK and Swiss market requirements.

Skills

• Expertise in regulatory compliance, vigilance, and technical documentation management.
• Proven ability to interface professionally with regulatory bodies such as the MHRA and Swissmedic.
• Strong communication skills, capable of briefing executive-level leadership.
• Self-motivated with a commitment to continuous professional development.
• Strong collaborative mindset to work effectively within a multidisciplinary team.

How To Apply

Interested candidates should apply through Randstad's website, providing a detailed CV and cover letter outlining their qualifications and experience.

Randstad Business Support is acting as an Employment Business in relation to this vacancy.