EU Regulatory Affairs Director: MAA Strategy & UK

Viking Therapeutics; Dublin; On-site; EUR 140,000 - 210,000; Full time

Benefits offered by this job

Regulatory leadership role

Job summary

Viking Therapeutics, Inc. seeks a Director/VP Regulatory Affairs Europe to own European regulatory strategy for SC VK2735 and VK2735. You will drive the centralized MAA process, coordinate with EMA, and lead UK MHRA submissions while guiding cross-functional teams in EU/UK regulatory affairs.

Position is based in Dublin, Ireland, with up to 30% travel to the U.S. and EU markets. A senior candidate will bring 10+ years in regulatory affairs with strong European focus and hands-on MAA experience.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Advanced degree (MSc, PhD, PharmD or equivalent) preferred.
• 10+ years in pharmaceutical/biotech, with extensive European regulatory experience for Director; 13+ years for Senior Director, with regulatory leadership in MAA processes.

Responsibilities

• Own European regulatory strategy for SC VK2735 and VK2735, translating a US-led program into EU filing plans.
• Lead the MAA under centralized procedure, including eligibility, Rapporteur engagement, pre-submission meetings, and EU eCTD Module 1.
• Plan and lead EMA Scientific Advice and Protocol Assistance, and advise national authorities.
• Manage notified body opinions for the autoinjector, ensuring device documentation aligns with MAA timelines.
• Lead UK regulatory strategy and MHRA submissions, including International Recognition Procedure and UK requirements.
• Represent Regulatory on cross-functional teams and contribute EU Module 2 and EU-specific Module 1 documents.
• Perform quality control of submission documents for accuracy and compliance.

Skills

Regulatory strategy

EU regulatory affairs

Project leadership

English communication

Cross-functional collaboration

Education

Bachelor’s degree in science

Advanced degree preferred

Job description

Viking Therapeutics, Inc. seeks a Director/VP Regulatory Affairs Europe to own European regulatory strategy for SC VK2735 and VK2735. You will drive the centralized MAA process, coordinate with EMA, and lead UK MHRA submissions while guiding cross-functional teams in EU/UK regulatory affairs.

Position is based in Dublin, Ireland, with up to 30% travel to the U.S. and EU markets. A senior candidate will bring 10+ years in regulatory affairs with strong European focus and hands-on MAA experience.