We are looking for a highly experienced Deputy Regulatory Affairs Manager – EU Lifecycle Management to support our growing EU Regulatory Affairs function.

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

Key Responsibilities

Manage and support EU lifecycle submissions, including Type IA, IAIN, IB and Type II variations.
Provide regulatory strategy for variation classification, grouping, work-sharing, 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 responses to authority questions, validation issues and clock-stops.
Liaise with corporate RA teams, internal departments, external partners, consultants and regulatory authorities.
Mentor RA team members and support development of RA procedures, trackers and working practices.

Requirements

Degree in Pharmacy, Life Sciences, Pharmaceutical Sciences, Chemistry or related discipline.
Minimum 10 years’ Regulatory Affairs experience within the pharmaceutical industry.
Strong hands-on experience in EU post-authorisation lifecycle management.
Experience with both safety-related and CMC-related variations.
Good knowledge of DCP, MRP and national procedures.
Strong understanding of EU variation requirements, CMDh/HMA guidance, eAF requirements and regulatory submission processes.
Experience reviewing submissions and identifying regulatory gaps before filing.
Excellent organisational, communication and problem-solving skills.
Fluent written and spoken English.

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.

Deputy Regulatory Affairs Manager - EU Lifecycle Management

Job Description