Director of Regulatory Affairs

About the Position

Director of Regulatory Affairs | Cpl Jobs

Location: Dublin City Centre, Ireland

Salary: €150,000 - €165,000

Type: Full-time, permanent

Travel: Up to 30%, including within the EEA and UK, and to the US HQ

Our client, a US-headquartered biotech, is a high potential start-up with a new European HQ in Dublin. This role is the company's senior-most regulatory presence in Europe, responsible for establishing the European regulatory function.

Responsibilities

• Own European regulatory strategy and execution, leading the Marketing Authorization Application (MAA) for under the centralised procedure.
• Manage the assessment clock, CHMP question responses, oral explanation preparation, and labelling negotiation through CHMP opinion and European Commission decision, plus pricing and reimbursement.
• Plan and lead EMA Scientific Advice and Protocol Assistance procedures and national competent authority advice.
• Lead UK regulatory strategy and MHRA submission, including route selection (e.g. International Recognition Procedure) and UK QPPV/Responsible Person requirements.
• Represent Regulatory on cross-functional teams, providing the European position on clinical, nonclinical, and CMC matters, and contributing EU-specific CTD content.
• Support inspection readiness across the company and its contracted CROs/CMOs, including EU and UK GCP/GMP inspection preparation and pre-authorisation inspection support in a fully outsourced model.
• Serve as the primary European interface to the US regulatory team, maintaining a single source of truth for submission content, health authority correspondence, and commitments across regions, and supporting US NDA activities as needed.
• Identify and escalate regulatory risks to the VP of Regulatory Affairs with supporting analysis and options.

Requirements

• Bachelor's degree in a scientific discipline required; advanced degree (MSc, PhD, PharmD or equivalent) preferred.
• Minimum 10 years of pharmaceutical/biotech industry experience, including at least 8 years in Regulatory Affairs.
• Demonstrated hands-on experience on at least one MAA submitted through the centralised procedure.
• Senior Director candidates will have led an MAA through the assessment procedure to CHMP opinion; Director candidates require substantive core-team contribution across the procedure.
• Experience with the UK regulatory framework post-EU exit, including MHRA national procedures and the International Recognition Procedure, and awareness of Northern Ireland supply requirements.
• Experience in metabolic, endocrine, or cardiometabolic therapeutic areas, or with peptide therapeutics, is preferred.
• Drug-device combination product experience (autoinjector/pen presentations, notified body interactions, human factors/design control interfaces) is preferred.
• Legally authorised to work in Ireland without company sponsorship.
• Ability to operate effectively as the sole European regulatory presence within a US-headquartered organisation.

We Offer

• Competitive salary range of €150,000 - €165,000 per year.
• Full-time, permanent position with up to 30% travel.
• Opportunity to work with a high potential biotech startup.
• Be part of a dynamic team in a growing European HQ.

About the Company

Cpl is a leading recruitment and HR services company, providing expert staffing solutions across various sectors. Our client is a US-headquartered biotech with a new European HQ in Dublin, committed to innovation and excellence in the pharmaceutical industry.