VP, Global Regulatory Strategy & Submissions

Celea Therapeutics; Boston (MA); Hybrid; USD 330,000 - 375,000; Full time

Job summary

Celea Therapeutics, based in the Greater Boston area with a hybrid work model, seeks an experienced Vice President of Regulatory Affairs to lead global strategy and agency interactions as deupirfenidone advances through Phase 3.

The role reports to the Chief Medical Officer and will own submissions across programs, build scalable processes, and mentor the regulatory team to drive toward registration and commercialization.

Qualifications

• Bachelor’s degree in life sciences; advanced degree preferred or equivalent experience.
• 15+ years in Regulatory Affairs with 7+ years in leadership and management.
• Experience leading regulatory filings (IND, NDA, BLA, MAA) through submission and lifecycle.
• Track record of global regulatory filings and agency interactions (FDA/EMA).
• Deep understanding of drug development, commercialization, and lifecycle management.
• Excellent communication, influencing cross-functionally and collaboration.
• Entrepreneurial mindset; thrive in fast-paced, early-stage environments.
• Proficiency with AI tools to improve quality and speed of work.

Responsibilities

• Lead global Regulatory Affairs strategy and tactical plans across programs.
• Oversee regulatory submissions and interactions from pre-IND through NDA/MAA and global health authorities.
• Develop relationships with FDA and international authorities as primary liaison.
• Review key development documents and labeling, risk management plans.
• Design scalable regulatory structures, processes, and AI-enabled workflows.
• Partner with clinical, preclinical, CMC, quality, and commercial teams for guidance.
• Ensure regulatory compliance, inspections, and audits; review materials.
• Lead regulatory advisory boards and support due diligence and business development.
• Recruit, mentor, and develop a high-performing regulatory team.

Skills

Leadership experience

Global regulatory filings

Regulatory strategy

Communication skills

Entrepreneurial mindset

AI tools proficiency

Regulatory submissions

Drug development understanding

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Celea Therapeutics, based in the Greater Boston area with a hybrid work model, seeks an experienced Vice President of Regulatory Affairs to lead global strategy and agency interactions as deupirfenidone advances through Phase 3.

The role reports to the Chief Medical Officer and will own submissions across programs, build scalable processes, and mentor the regulatory team to drive toward registration and commercialization.