Senior Regulatory Affairs Specialist — Pharmaceutical, Ireland (Contract)

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

Role Overview

The successful candidate will manage regulatory submissions and lifecycle activities for an assigned product portfolio, working to HPRA and EMA requirements throughout. This is a hands-on, execution-focused role suited to an experienced regulatory professional who can be effective quickly, with minimal ramp-up time, in a fast-moving submission environment.

Role Overview

The successful candidate will manage regulatory submissions and lifecycle activities for an assigned product portfolio, working to HPRA and EMA requirements throughout. This is a hands-on, execution-focused role suited to an experienced regulatory professional who can be effective quickly, with minimal ramp-up time, in a fast-moving submission environment.

Key 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.

Essential Qualifications & Experience

• Degree in a life sciences discipline (pharmacy, chemistry, biology, or related field).
• Substantial experience in a regulatory affairs role 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.

Desirable Criteria

• Experience with a specific product category (e.g. generics, biologics, medical devices, or OTC) relevant to the company's portfolio.
• Prior contract/interim regulatory affairs experience, with the ability to add value quickly in an unfamiliar portfolio.
• Experience representing the company at regulatory authority meetings or scientific advice procedures.
• Membership of a relevant professional body (e.g. TOPRA — The Organisation for Professional Regulatory Affairs).
• Experience managing regulatory aspects of due diligence for licensing, M&A, or portfolio transfer activities.

Person Specification

• Highly organised, with strong attention to detail and the ability to manage complex, deadline-driven submission activity.
• Self-sufficient and effective from day one, able to integrate quickly into an established regulatory team and unfamiliar portfolio.
• Confident, credible communicator, comfortable representing the company directly with regulatory authorities.
• Collaborative, able to work effectively with cross-functional teams without extended onboarding time.
• Proactive and solutions-focused when navigating regulatory ambiguity or evolving guidance.