Europe Regulatory Affairs Director – Dublin

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

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.