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.
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