EU Regulatory Submissions Lead — Lifecycle & Compliance

Myn; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Myn in Ireland is seeking an experienced regulatory affairs professional to oversee submissions and lifecycle activities for an assigned product portfolio, ensuring compliance with HPRA and EMA requirements. This hands-on role is execution-focused and suited to someone who can contribute quickly with minimal ramp-up in a fast-moving submission environment.

You will manage strategic submissions, coordinate with R&D, Quality, and Manufacturing, and maintain audit-ready documentation.

Qualifications

• Degree in a life sciences discipline (pharmacy, chemistry, biology, or related field).
• Substantial experience in regulatory affairs within the pharmaceutical industry, with demonstrable experience managing submissions under HPRA/EMA oversight.
• Strong working knowledge of EU pharmaceutical legislation (Directive 2001/83/EC, Regulation (EC) No 726/2004), EU variations regulation, and HPRA national guidance.
• Proven track record of successful marketing authorisation submissions and lifecycle management, ideally spanning multiple procedure types.
• Strong project management skills, capable of managing multiple submissions and competing deadlines simultaneously.
• Available to start within a short notice period, given the contract nature of the role.

Responsibilities

• Prepare, compile, and submit high-quality regulatory dossiers via the Centralised, Decentralised, Mutual Recognition, or National procedures, as appropriate.
• Manage submissions through CESP/eSubmission Gateway and the EMA's IRIS platform, ensuring accuracy, completeness, and adherence to eCTD/CTD format standards.
• Lead or support lifecycle management activities, including variations, renewals, and labelling updates, working to agreed timelines.
• Act as a regulatory point of contact for assigned products, responding to regulatory authority queries and deficiency letters within required timeframes.
• Review and approve labelling, packaging, and promotional materials for regulatory compliance.
• Maintain regulatory information management systems and ensure documentation is audit-ready at all times.
• Provide regulatory input into cross-functional project teams, including R&D, Quality, and Manufacturing, as required.
• Support due diligence, product transfer, or portfolio rationalisation activities where applicable to the contract scope.
• Monitor evolving regulatory guidance and legislation, flagging impact on the assigned product portfolio.
• Maintain accurate tracking of submission status and deadlines across the assigned portfolio.

Skills

Regulatory submissions

Lifecycle management

Cross-functional collaboration

Project management

Education

Life sciences degree

Job description

Myn in Ireland is seeking an experienced regulatory affairs professional to oversee submissions and lifecycle activities for an assigned product portfolio, ensuring compliance with HPRA and EMA requirements. This hands-on role is execution-focused and suited to someone who can contribute quickly with minimal ramp-up in a fast-moving submission environment.

You will manage strategic submissions, coordinate with R&D, Quality, and Manufacturing, and maintain audit-ready documentation.