Associate Director, Regulatory Strategy

Job overview

The Associate Director, Regulatory Strategy role is onsite in Cambridge, MA, with compensation of $175,000–$225,000 per year. Scholar Rock develops treatments for spinal muscular atrophy and other rare neuromuscular diseases. This role develops and implements regulatory strategies for assigned clinical and pipeline programs, guiding agency engagement and submissions while advising cross-functional teams on regulatory risks, opportunities, and requirements.

What you'll do

• Develop regulatory strategies and roadmaps for assigned programs
• represent regulatory affairs on cross-functional teams
• lead regulatory-authority interactions and submissions, including INDs, briefing documents, DSURs, and BLAs
• gather and communicate regulatory intelligence
• identify risks and mitigation options
• manage ClinicalTrials.gov disclosures
• and provide regulatory support for related activities.

What we're looking for

Skills & competencies

associate director

regulatory strategy

regulatory affairs

biopharmaceutical

clinical programs

pipeline programs

cambridge ma

scholar rock

full-time

$175k–$225k/year

rare diseases

monoclonal antibodies

Work arrangement

• Weekend coverage required

Why this role

The role supports Scholar Rock’s anti-myostatin therapy and regulatory work for a new indication of an approved product; approximately 10% domestic and international travel is required.

About the employer

Scholar Rock is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.