Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Associate Director - Regulatory Strategy

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeCambridge, MA, USA$175k - $225k /yr

About the Job

Requirements

Education in life sciences is required.
Candidates must be located in the greater Boston area.
At least 5 years of experience in the biopharmaceutical industry, with broad experience in regulatory affairs and drug development, is required.
Demonstrated experience leading successful engagement with key regulatory agencies is required.
Expertise and experience with biologics, particularly monoclonal antibody therapeutics, and rare diseases are strongly preferred but not required.
Demonstrated reputation as a well-respected, dynamic team leader with strong leadership and people-management skills is required.
Strong written and verbal communication skills and interpersonal skills are required.
Ability to manage shifting priorities in a rapidly changing environment is required.
Ability to travel domestically and internationally approximately 10% is required.

Responsibilities

Serve as a thought leader in regulatory affairs, defining regulatory strategy and plans to maximize regulatory success for the next-generation anti-myostatin therapy and serving as the U.S. regulatory representative for a new indication for an approved product.
Represent regulatory affairs on cross-functional teams to ensure compliance with regulations.
Provide strategic and operational input to program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements.
Develop a regulatory roadmap to inform and guide agency-engagement strategy, and partner with key stakeholders to develop and implement a comprehensive regulatory-engagement plan.
Serve as the point of contact with regulatory authorities, leading and managing regulatory interactions and building trusted relationships with regulatory authorities.
Lead cross-functional efforts to ensure timely submission of key regulatory documents, including INDs, briefing documents, DSURs, and BLAs.
Gather regulatory intelligence, synthesize it, and communicate relevant information to stakeholders.
Identify regulatory risks and opportunities and work with key stakeholders to develop solutions and risk mitigations.
Conduct regulatory research to inform development strategies.
Manage ClinicalTrials.gov disclosure for programs across the portfolio.
Provide regulatory support for cross-functional activities, including SOPs, business development, clinical labeling, and disclosure, as needed.

Desired Qualifications

Expertise and experience with biologics, particularly monoclonal antibody therapeutics, and rare diseases are strongly preferred but not required.

Salary Range: 175000 to 225000 (Currency: USD) (Pay period: per-year-salary)

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.

About the Company

Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Scholar Rock develops biopharmaceutical therapies by targeting protein growth factors to treat diverse diseases. Its work hinges on a proprietary drug discovery platform that identifies ways to modulate these growth factors, enabling creation of novel therapeutic solutions. The company advances its programs through research and development, and collaborates with other biopharmaceutical companies and research institutions, earning revenue via licensing agreements, milestone payments, and eventual product sales. Scholar Rock differentiates itself by focusing on protein growth factors and pursuing targets and indications that have been historically overlooked, with a strong emphasis on partnerships and patient-centric approaches. The overall goal is to deliver safe and effective therapies that improve patient outcomes by precisely modulating growth factor pathways through collaborative science.

Company size: 201-500
Company stage: IPO
Headquarters: Cambridge, MA
Founded: 2012

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