Associate Director, Regulatory Strategy

Regulatory Toolkit; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Scholar Rock, a biopharma company focused on muscle biology, is seeking an Associate Director, Regulatory Strategy in the greater Boston area. You will shape regulatory strategy for clinical and pipeline programs and lead agency communications to advance anti-myostatin therapies and other neuromuscular programs.

The role requires life sciences education, 5+ years in regulatory affairs, and proven leadership in regulatory submissions (IND/DSUR/BLA).

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 leading engagement with key regulatory agencies.
• Biologics/monoclonal antibodies expertise strongly preferred.
• Strong leadership and people management skills.
• Strong written and verbal communication skills.
• Ability to travel domestically and internationally ~10%.

Responsibilities

• Define regulatory strategy and plan to maximize regulatory success for next-gen anti-myostatin therapy.
• Regulatory representative on cross-functional teams to ensure compliance with regulations.
• Provide strategic input to program teams to meet objectives and ensure compliance.
• Develop regulatory roadmaps and engagement plans with key stakeholders.
• Lead interactions with regulatory authorities and manage agency submissions and correspondence.
• Coordinate submission of key documents (IND, briefing documents, DSUR, BLA).
• Conduct regulatory research to inform development strategies.
• Manage Clinicaltrials.gov disclosures for programs.

Skills

Regulatory strategy

Leadership

Regulatory submissions

Communication

Education

Life sciences degree

Job description

Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.

As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical 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 about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Summary of Position:

The Associate Director, Regulatory Strategy, is responsible for the development and implementation of regulatory strategy and plan for assigned clinical and/or pipeline programs. 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 to the appropriate regulatory agencies.

Position Responsibilities

• Serve as a thought leader on regulatory affairs, defining regulatory strategy and plan to maximize regulatory success in our next generation anti-myostatin therapy and US regulatory representative for new indication for an approved product.
• Regulatory representative on cross-functional teams to ensure compliance with regulations
• Provide strategic and operational input to program team to achieve program objectives while ensuring compliance with applicable regulatory requirements
• Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
• Serve as point of contact with regulatory authorities, leading and managing regulatory interactions, building trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., IND, briefing documents, DSUR, BLA)
• Regulatory intelligence gathering, synthesizing and communicating to stakeholders., relevant
• Identify regulatory risks and opportunities and work with key stakeholders to develop solutions/risk mitigations
• Conduct regulatory research to help inform development strategies
• Manage the Clinicaltrials.gov disclosure for programs across the portfolio.
• Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Candidate Requirements

• 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 (
• 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%)

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees