Sr. Director, Regulatory Strategy

Requirements

• Education in life sciences required
• Greater Boston-based with ability to be regularly present in the Cambridge, MA office
• 7+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of EU regulatory requirements
• Demonstrated experience of leading successful engagement with EMA
• Expertise and experience with biologics (particularly monoclonal antibody therapeutics) and rare diseases strongly preferred but not required
• Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people management skills
• Strong written, verbal communication skills, and interpersonal skills
• Capable of managing shifting priorities in a rapidly changing and environment
• Ability to travel domestically and internationally (~10%)

Additional Information

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn. Summary of Position: The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is responsible for the development and implementation of the Global Strategy for assigned clinical and/or pipeline programs globally depending on the program. As a subject matter expert, this individual will represent regulatory affairs at the appropriate program team, highlighting risks and opportunities to inform program strategy and plan. The successful candidate will lead interactions with the regulatory authorities, directing the preparation and submission of regulatory submissions and correspondence. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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