Parkside Recruitment
Senior Regulatory Specialist
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We are seeking an experienced Regulatory Affairs Manager to lead regulatory activities across our UK affiliate. This is an exciting opportunity to play a pivotal role in ensuring regulatory compliance, driving regulatory strategy, and supporting the lifecycle management of a diverse pharmaceutical portfolio.
Working closely with UK, European and Global stakeholders, you will provide expert regulatory leadership, manage a high-performing Regulatory Affairs team, and represent the organisation in interactions with the MHRA and other regulatory authorities.
Key Responsibilities
- Lead UK regulatory activities for marketed products, including regulatory strategy, submissions, approvals, and lifecycle management.
- Manage preparation, review, and submission of regulatory documentation, including CTD dossiers and post-authorisation activities.
- Lead regulatory projects including new registrations, variations, renewals, Scientific Advice meetings, PIPs, and Orphan Drug Designations.
- Provide regulatory input into product development strategies and support EU/UK regulatory planning.
- Represent Regulatory Affairs in cross-functional teams and provide expert advice on regulatory requirements and risks.
- Manage interactions with the MHRA, including responses to regulatory questions and meetings.
- Ensure regulatory databases, trackers, SOPs, and controlled documents are maintained and compliant.
- Support labelling activities, including SmPCs, PILs, and product information updates.
- Drive continuous improvement of regulatory processes and support audit readiness.
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Essential Experience & Skills
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- Degree in Life Sciences or a related scientific discipline.
- Approximately 7 years’ experience in Regulatory Affairs within the pharmaceutical industry.
- Experience with CTD documentation, MAAs, national and centralised procedures.
- Strong understanding of post-marketing activities.
- Experience interacting with the MHRA and managing regulatory authority responses.
- Knowledge of SmPCs, PILs, labelling requirements, and regulatory compliance processes.
- Strong project management, organisational, and stakeholder management skills.
- Ability to influence cross-functional teams and work effectively in a global environment.
- Experience writing SOPs, improving processes, and maintaining regulatory compliance.
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