EU Regulatory Affairs Director: MAA & UK Strategy

Viking Therapeutics, Inc.; Dublin; On-site; EUR 120,000 - 180,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a seasoned Director/Senior Director of Regulatory Affairs Europe to own regulatory strategy and execute MAA submissions under centralized procedure for SC VK2735 and oral VK2735.

This role oversees EU/HMRA strategy, UK submission pathways, and cross-functional collaboration with internal teams and CROs. Based in Dublin, Ireland, the position requires deep European regulatory experience, strong leadership, and hands-on contribution to regulatory content, with

Qualifications

• Demonstrated regulatory leadership for EU/UK submissions.
• Experience leading MAA under centralized procedure.
• Proven ability to work with cross-functional teams and consultants.

Responsibilities

• Own European regulatory strategy for EU/UK.
• Lead MAA under centralized procedure and manage submissions.
• Plan EMA interactions, pre-submission activities, and dossier assembly.
• Coordinate with UK MHRA strategy and national routes as needed.
• Ensure quality control of submission documents and cross-reference accuracy.
• Support inspection readiness and EU/UK health authority interactions.
• Serve as primary European interface to US regulatory team.

Skills

EU regulatory strategy

MAA submission

UK MHRA knowledge

Regulatory leadership

Cross-functional teamwork

English communication

Education

Bachelor's in science

Advanced degree preferred

Job description

Viking Therapeutics, Inc. seeks a seasoned Director/Senior Director of Regulatory Affairs Europe to own regulatory strategy and execute MAA submissions under centralized procedure for SC VK2735 and oral VK2735.

This role oversees EU/HMRA strategy, UK submission pathways, and cross-functional collaboration with internal teams and CROs. Based in Dublin, Ireland, the position requires deep European regulatory experience, strong leadership, and hands-on contribution to regulatory content, with