Role Overview
The Regulatory Affairs Manager will lead day-to-day regulatory activities for the manufacturing site, providing expert Regulatory CMC guidance and ensuring compliance with GMP and regulatory requirements. The role combines hands-on regulatory work with people management, supporting global regulatory strategies and local site operations.
Key Responsibilities
Team Leadership
- Lead and develop a small Regulatory Affairs team, ensuring performance, compliance, and professional development.
- Provide mentoring, guidance, and decision-making support.
- Manage departmental resources and budget to meet current and future regulatory needs.
Regulatory Operations
- Plan and oversee MAAs, variations, renewals, and post-approval activities in assigned territories.
- Actively support and manage complex and critical regulatory submissions.
- Ensure timely, compliant submissions to EU and other regulatory authorities using validated publishing tools.
Regulatory CMC
- Maintain oversight of CTD Modules 2.3 and 3 across applicable markets.
- Assess regulatory impact of changes to products, processes, and facilities through change control.
- Track and manage CMC changes across multiple territories.
- Lead preparation, review, and adaptation of CMC documentation to meet regional requirements.
GMP & Regulatory Quality Assurance
- Ensure alignment between registered dossiers and site/manufacturing operations.
- Oversee regulatory compliance for manufacturing, packaging, testing, and distribution activities.
- Review GMP documentation, product artwork, and other regulated materials from a regulatory perspective.
- Support inspections, audits, and preparation of responses to Health Authority queries.
- Ensure regulatory commitments are reflected in site operations.
Authority Interactions
- Act as the primary regulatory contact with Health Authorities (e.g., HPRA, EMA).
- Manage regulatory correspondence, meetings, and responses.
Cross-Functional Collaboration
- Work closely with global regulatory, Quality, Manufacturing, Supply Chain, R&D, and Commercial teams.
- Provide regulatory guidance and support to internal and external stakeholders.
- Communicate regulatory changes and submission requirements effectively.
Qualifications & Experience
- Degree in Pharmacy, Life Sciences, or related discipline (postgraduate qualification advantageous).
- Minimum 7 years' experience in Regulatory CMC within the pharmaceutical industry (EU/global).
- At least 4 years' experience in CMC regulatory writing.
- Experience in Regulatory Quality Assurance highly desirable.
- Strong knowledge of EU regulatory procedures (CP, DCP, MRP, national); ROW experience is a plus.
- Solid understanding of GMP, GDP, and pharmaceutical quality systems.
- Experience supporting regulatory inspections and audits.
- Proven project management and cross-functional collaboration skills.
