Director of Regulatory Affairs

Cpl; Dublin; On-site; EUR 180,000 - 240,000; Full time

Job summary

Our client, a US-headquartered biotech startup establishing a European HQ in Dublin, seeks a Senior Director/Director, Regulatory Affairs to own European regulatory strategy and to lead the MAA under the centralised procedure.

You will oversee EU/UK regulatory activities, coordinate with the US team, and guide EU/UK consultants, with regular on-site presence in Ireland and periodic travel to San Diego.

Qualifications

• Minimum 10 years in pharma/biotech with 8+ years in Regulatory Affairs
• Hands-on experience leading at least one MAA via centralised procedure
• Experience with UK regulatory framework post-EU exit (MHRA, International Recognition Procedure)

Responsibilities

• Own European regulatory strategy and execution.
• Lead MAA submission and CHMP interactions from planning to EC decision.
• Coordinate EMA Scientific Advice/Protocol Assistance and national authority advice.
• Manage UK regulatory strategy and MHRA submissions.
• Represent regulatory on cross-functional teams and maintain EU CTD content.
• Support inspection readiness and pre-authorisation inspections.
• Serve as primary European interface to US regulatory team and align submissions.

Skills

Regulatory Affairs

MAA submission

EU regulatory strategy

UK MHRA procedure

GxP knowledge

Education

Bachelor's degree in science

MSc/PhD/PharmD preferred

Job description

Senior Director / Director, Regulatory Affairs – Europe

Location: Ireland (with regular on-site presence at the Irish location, and periodic travel to San Diego)

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 new European HQ in Dublin.

Role:

Own European regulatory strategy and execution and to lead the Marketing Authorization Application (MAA) for under the centralised procedure, followed by the corresponding application

This is the company's senior-most regulatory presence in Europe, with responsibility for establishing the European regulatory function. There are no direct reports initially; the role provides day-to-day direction to EU and UK regulatory consultants, the outsourced submission publishing vendor, and local representative arrangements. The role reports to the VP of Regulatory Affairs (San Diego).

Key Responsibilities

• Own European regulatory strategy, translating a US-led development programme into an EU filing plan.
• 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 escalation 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.