Global Regulatory Strategy VP — Lead Biotech Submissions

Scholarrock; Cambridge (MA); On-site; USD 250,000 - 360,000; Full time

Job summary

Scholar Rock seeks a Vice President, Head of Regulatory Strategy to direct global regulatory strategy across its portfolio. Based near Boston with regular Cambridge presence, you will lead regulatory interactions, plan submissions, and advise program teams to maximize regulatory success.

The role requires 15+ years in regulatory affairs, with strong leadership and biologics expertise guiding cross-functional teams.

Qualifications

• Education in life sciences required.
• 15+ years Regulatory Affairs experience in biopharma with US/EU understanding.
• Experience leading FDA/EMA engagements and submissions.
• Expertise with biologics (monoclonal antibodies) and rare diseases preferred.
• Demonstrated leadership, strategic thinking and people management.
• Willingness to travel ~20% and be based in Greater Boston/Cambridge.

Responsibilities

• Define and lead global regulatory strategy across portfolio.
• Lead interactions with regulatory authorities and manage submissions.
• Serve as regulatory thought leader in program teams and governance bodies.
• Develop regulatory roadmaps and engagement plans with stakeholders.
• Ensure timely regulatory deliverables and proactive risk management.
• Collaborate with global market access and medical affairs teams.

Skills

Regulatory Leadership

FDA/EMA Engagement

Global Regulatory Strategy

Biologics Expertise

People Management

Communication Skills

Education

Life Sciences degree

Job description

Scholar Rock seeks a Vice President, Head of Regulatory Strategy to direct global regulatory strategy across its portfolio. Based near Boston with regular Cambridge presence, you will lead regulatory interactions, plan submissions, and advise program teams to maximize regulatory success.

The role requires 15+ years in regulatory affairs, with strong leadership and biologics expertise guiding cross-functional teams.