Regulatory Affairs Manager - Pharmaceuticals
We are seeking an experienced Regulatory Affairs Manager to lead the regulatory function for a pharmaceutical organisation. This is a strategic and hands-on role, responsible for managing regulatory activities, ensuring GMP compliance, and supporting CMC and quality assurance operations at a manufacturing site.
Key Responsibilities:
- Lead and develop a high-performing Regulatory Affairs team, ensuring compliance and continuous improvement.
- Oversee regulatory submissions (MAAs, variations, renewals) across EU and international markets.
- Support and review CMC documentation and manage regulatory aspects of product lifecycle management.
- Ensure compliance between manufacturing operations and registered product dossiers.
- Act as the main point of contact with health authorities, managing correspondence and regulatory inspections.
- Collaborate with cross-functional teams including Quality, R&D, and Supply Chain to ensure alignment with regulatory requirements.
- Monitor regulatory changes and implement necessary updates to internal processes.
Requirements:
- Degree in Pharmacy, Life Sciences, or a related field; postgraduate qualifications in Regulatory Affairs are a plus.
- Minimum 5 years' experience in Regulatory Affairs within the pharmaceutical industry
- Minimum 1 year in a team leadership position within the pharmaceutical industry.
- Strong background in CMC submissions and regulatory quality assurance.
- Solid knowledge of EU regulatory procedures (CP, DCP, MRP); experience with global markets is advantageous.
- Excellent communication, leadership, and project management skills.
- In-depth understanding of GMP, GDP, and pharmaceutical quality systems.
This role is ideal for a regulatory professional who thrives in a dynamic environment and is looking to take the next step in their leadership journey.