Global Regulatory Strategy Leader

Scholar Rock; Cambridge (MA); On-site; USD 305,000 - 360,000; Full time

Job summary

Scholar Rock in Cambridge, MA seeks a strategic Vice President, Head of Regulatory Strategy to shape global regulatory plans and lead interactions with regulators across the portfolio.

The role require 15+ years in regulatory affairs, deep biologics experience, and the ability to travel ~20%. You will drive regulatory roadmaps, align with market access and commercial teams, and ensure timely, compliant submissions.

Qualifications

• Education in life sciences.
• 15+ years of Regulatory Affairs experience in biopharmaceuticals.
• Proven track record leading FDA and EMA engagements.
• Experience with biologics and rare diseases preferred.
• Willingness to travel domestically and internationally (~20%).

Responsibilities

• Define global regulatory strategy and plan to maximize success.
• Lead global regulatory interactions for portfolio programs with regulators.
• Develop regulatory roadmaps and agency engagement plans.
• Ensure timely submissions and cross-functional alignment.
• Maintain currency on regulatory requirements across regions.
• Mentor and lead regulatory team members.

Skills

Regulatory strategy leadership

Cross-functional leadership

Regulatory affairs expertise

Communication skills

Education

Life sciences degree

Job description

Scholar Rock in Cambridge, MA seeks a strategic Vice President, Head of Regulatory Strategy to shape global regulatory plans and lead interactions with regulators across the portfolio.

The role require 15+ years in regulatory affairs, deep biologics experience, and the ability to travel ~20%. You will drive regulatory roadmaps, align with market access and commercial teams, and ensure timely, compliant submissions.