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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.
Job 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.
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