Europe Regulatory Strategy Lead, Ireland-Based, Global

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

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.