Regulatory Strategy Director - Biologics & Rare Diseases

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

Job summary

Scholar Rock is seeking an Associate Director, Regulatory Strategy, to lead development and execution of regulatory plans for clinical and pipeline programs. You will represent regulatory affairs in program teams, highlighting risks and opportunities to inform strategy and plan.

You will lead interactions with regulatory authorities, directing preparation and submission of regulatory documents and communications to agencies, ensuring timely and compliant outcomes across programs.

Qualifications

• Education in life sciences required.
• Located in the greater Boston area required.
• 5+ years in biopharma with regulatory affairs exposure.

Responsibilities

• Define regulatory strategy and plan for programs to maximize regulatory success.
• Lead interactions with regulatory authorities and manage submissions (IND, DSUR, BLA).
• Provide strategic input to cross-functional teams to ensure regulatory compliance.
• Develop and implement a regulatory engagement plan with agency stakeholders.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory affairs

Written communications

Education

Life sciences degree

Tools

Regulatory submissions

Job description

Scholar Rock is seeking an Associate Director, Regulatory Strategy, to lead development and execution of regulatory plans for clinical and pipeline programs. You will represent regulatory affairs in program teams, highlighting risks and opportunities to inform strategy and plan.

You will lead interactions with regulatory authorities, directing preparation and submission of regulatory documents and communications to agencies, ensuring timely and compliant outcomes across programs.