Myn
Senior Regulatory Affairs Specialist — Pharmaceutical, UK (Contract)
London
Posted about 19 hours ago
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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.
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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.
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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.
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