Regulatory Affairs Specialist – EU Lifecycle Management

We are seeking an experienced Regulatory Affairs Specialist to support our growing EU Regulatory Affairs function.

This role is focused on EU post-authorisation lifecycle management, including safety-related and CMC-related regulatory activities.

Key Responsibilities:

• Prepare, review and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.
• Support variation classification, grouping, worksharing, implementation dates and submission planning.
• Support safety-related lifecycle updates, including Product Information updates, RMP-related changes, PSUR outcomes, referrals and reference product updates.
• Support CMC lifecycle changes, including manufacturing site changes, analytical methods, specifications, stability, suppliers, packaging, batch release and testing sites.
• Prepare, review and coordinate SmPC, labelling and package leaflet updates.
• Support renewals, regulatory commitments and lifecycle tracking activities.
• Prepare and support responses to authority questions, validation issues and clock-stops.
• Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.
• Maintain RA trackers, submission plans and regulatory documentation.
• Contribute to the development of RA procedures, templates and working practices.

Requirements:

• Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.
• Minimum 5 years’ Regulatory Affairs experience within the pharmaceutical industry.
• Hands-on experience in EU post-authorisation lifecycle management.
• Experience with safety-related and/or CMC-related variations.
• Good knowledge of DCP, MRP and national procedures.
• Understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.
• Ability to review regulatory documentation and identify gaps before submission.
• Excellent organisational, communication and problem-solving skills.
• Fluent written and spoken English.
• Eligibility to work in Malta / EU.

Preferred Experience:

• Experience with generic medicinal products.
• Experience with multi-country EU regulatory portfolios.
• Experience with eCTD lifecycle submissions and electronic submission systems.

What We Offer:

• Competitive remuneration package.
• Comprehensive health insurance.
• Professional development and training opportunities.
• Exposure to a broad European pharmaceutical portfolio.
• Opportunity to contribute to the development of a growing EU Regulatory Affairs function in Malta.