Senior Regulatory Strategy Lead, Biologics

Scholar-Rock; Cambridge (MA); On-site; USD 175,000 - 225,000; Full time

Job summary

Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions and correspondence to agencies.

The candidate will drive regulatory roadmaps, manage INDs/BLAs, and partner with stakeholders to identify risks and opportunities, ensuring timely and compliant program advancement.

Qualifications

• Education in life sciences required.
• Located in the greater Boston area required.
• 5+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development.
• Demonstrated experience of leading successful engagement with key regulatory agencies (US, international).
• Expertise with biologics, monoclonal antibody therapeutics, and rare diseases is strongly preferred but not required.

Responsibilities

• Define regulatory strategy and plan to maximize regulatory success for programs.
• Lead interactions with regulatory authorities and manage submissions (IND, BLA, DSUR).
• Collaborate with cross-functional teams to align regulatory objectives with program goals.
• Develop regulatory engagement roadmaps and agency communication plans.
• Provide strategic input to programs on risks, opportunities, and mitigations.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Biologics experience

Team leadership

Education

Life sciences degree

Job description

Scholar Rock is seeking an Associate Director, Regulatory Strategy in the greater Boston area to lead the development and execution of regulatory plans for clinical and pipeline programs. This role represents regulatory affairs on cross-functional teams and directs submissions and correspondence to agencies.

The candidate will drive regulatory roadmaps, manage INDs/BLAs, and partner with stakeholders to identify risks and opportunities, ensuring timely and compliant program advancement.