VP Regulatory Affairs — Global Strategy & Submissions

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

Job summary

Celea Therapeutics is seeking an experienced Vice President of Regulatory Affairs to lead global regulatory strategy and serve as the primary FDA liaison as we advance deupirfenidone (LYT-100) through Phase 3. This role reports to the Chief Medical Officer and partners with the leadership team to shape regulatory filings and infrastructure for future registration and commercialization.

Based in the Greater Boston area with a hybrid work model, the candidate will build a scalable regulatory

Qualifications

• 15+ years in Regulatory Affairs within biotech/pharma.
• 7+ years in leadership and management roles.
• Led regulatory filings (IND, NDA, BLA, MAA) through submission and life-cycle management.
• Global regulatory filings and agency interactions with FDA/EMA.
• Deep understanding of drug development, commercialization, and lifecycle management.
• Excellent written and spoken communication; cross-functional influence.
• Entrepreneurial mindset for fast-paced environments.
• Proficiency using AI tools to enhance regulatory work.

Responsibilities

• Lead global regulatory strategy and tactical plans across programs.
• Oversee submissions and interactions from pre-IND to NDA/MAA worldwide.
• Build trusted relationships with FDA and international authorities.
• Provide regulatory oversight of preclinical, clinical, and CMC activities.
• Develop scalable regulatory structures, processes, and automation.
• Partner with clinical, preclinical, quality, and commercial teams; counsel on guidelines.
• Ensure regulatory compliance; lead inspections and audits; review labeling and promos.
• Lead regulatory advisory boards and support BD due diligence.
• Recruit, mentor, and scale a high-performing regulatory team.

Skills

Regulatory leadership

Regulatory strategy

Stakeholder management

Regulatory submissions

Cross-functional collaboration

Communication

AI tools / automation

Education

Bachelor’s degree in life sciences

Advanced degree (PhD/ PharmD/ MS) preferred

RAC certification preferred

Tools

AI tools

Job description

Celea Therapeutics is seeking an experienced Vice President of Regulatory Affairs to lead global regulatory strategy and serve as the primary FDA liaison as we advance deupirfenidone (LYT-100) through Phase 3. This role reports to the Chief Medical Officer and partners with the leadership team to shape regulatory filings and infrastructure for future registration and commercialization.

Based in the Greater Boston area with a hybrid work model, the candidate will build a scalable regulatory