Director of Regulatory Affairs

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

Job summary

Cpl Group, on behalf of a US-headquartered biotech with a new European HQ in Dublin, seeks a Senior Director/Director of Regulatory Affairs Europe to own the European regulatory strategy and lead the MAA under the centralised procedure.

You will oversee EU and UK regulatory activities, coordinate CHMP interactions, ensure inspection readiness, and act as the primary interface to the US team while reporting to the VP of Regulatory Affairs in San Diego.

Qualifications

• Bachelor’s degree in a scientific discipline required; MSc/PhD/PharmD preferred.
• Minimum 10 years in pharma/biotech with at least 8 years in Regulatory Affairs.
• Hands-on experience with at least one MAA submitted through the centralised procedure.
• Senior Director candidates should have led an MAA to CHMP opinion; Directors to contribute core team.
• Experience with UK post-EU exit regulatory framework, MHRA and IRP procedures.
• Metabolic, endocrine, or cardiometabolic areas, or peptide therapeutics experience preferred.

Responsibilities

• Own European regulatory strategy, translating a US-led program into an EU filing plan.
• Manage assessment clock, CHMP responses, oral explanations, labeling negotiations, pricing & reimbursement.
• Plan and lead EMA Scientific Advice and Protocol Assistance procedures.
• Lead UK regulatory strategy and MHRA submissions, including International Recognition Procedure.
• Represent Regulatory in cross-functional teams, shape EU CTD contents.
• Support inspection readiness across CROs/CMOs and liaise with EU/UK authorities.
• Serve as primary European interface to US regulatory team and report regulatory risks to VP.

Skills

Regulatory strategy

MAA submission

EU regulatory affairs

CHMP/EMA liaison

UK regulatory affairs

Cross-functional leadership

Regulatory risk management

Education

Bachelor's degree in a scientific discipline

MSc/PhD or 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 elevate 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.