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 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.