Scholar Rock

Biopharmaceutical firm targeting protein growth factors

Vice President, Head of Regulatory Strategy

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

Full-timeCambridge, MA, USA$305k - $360k /yr

About the Job

Requirements

Education in life sciences is required.
The candidate must be based in Greater Boston and able to be regularly present in the Cambridge, Massachusetts office.
At least 15 years of Regulatory Affairs experience in the biopharmaceutical industry, with a deep understanding of United States and European Union regulatory requirements, is required.
Demonstrated experience leading successful engagement with the Food and Drug Administration and European Medicines Agency is required.
The candidate must have strong written and verbal communication and interpersonal skills.
The candidate must be capable of managing shifting priorities in a rapidly changing environment.
The candidate must be able to travel domestically and internationally approximately 20% of the time.

Responsibilities

Build and lead the Global Regulatory Strategy team, which is responsible for developing global regulatory strategy across the portfolio.
Represent Regulatory Affairs as a subject matter expert on program teams, highlighting risks and opportunities to inform program strategy and plans.
Lead interactions with regulatory authorities and direct the preparation and submission of regulatory submissions.
Define global regulatory strategy and plans across the portfolio to maximize regulatory success.
Serve as global regulatory lead, providing strategic and operational input on assigned clinical and pipeline programs, including the subcutaneous and OPAL program teams, to achieve program objectives while ensuring compliance with applicable regional regulatory requirements.
Lead the global supplemental/type 2 variation filing for OPAL.
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.
Lead and manage regulatory interactions on assigned programs and build trusted relationships with regulatory authorities.
Lead cross-functional efforts to ensure timely submission of key regulatory documents.
Ensure program team members and cross-functional stakeholders are informed of internal and external events that may affect regulatory success.
Identify regulatory risks and opportunities and work with key stakeholders to develop solutions.
Partner with global market access and medical affairs colleagues, as applicable, to support interactions with joint regulatory, health agency, and health technology assessment bodies on product-specific value evidence topics.
Partner with global and local Marketing and Commercial teams as needed to align regulatory and marketing/commercial plans.
Ensure strong representation of the regulatory perspective at key governance bodies and teams, including DRC, program teams, clinical development teams, and study teams.
Maintain current knowledge of regulatory requirements and approvals to inform regulatory strategies and develop proactive plans to ensure compliance.
Monitor and analyze the global and country-specific regulatory landscape to assess potential program impacts, and collaborate with teams to ensure compliance.
Provide support to local regulatory experts.
Provide regulatory support for cross-functional activities, including standard operating procedures, 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: 305000 to 360000 (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 Vice President, Head of Regulatory Strategy, reporting to the SVP, Global Head of Regulatory Affairs, is accountable for building and leading the Global Regulatory Strategy team, responsible for the development of global regulatory strategy across the portfolio. 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.

Position Responsibilities

Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success across the portfolio.

Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.

Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)

Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan

Lead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authorities

Lead cross-functional effort to ensure timely submission of key regulatory document

Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success

Identify regulatory risks and opportunities and work with key stakeholders to develop solutions

Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable

Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan

Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)

Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance

Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance

Provide support to local regulatory experts

Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Candidate Requirements

Education in life sciences required
Greater Boston-based with ability to be regularly present in the Cambridge, MA office
15+ years of experience Regulatory Affairs in biopharmaceutical industry with deep understanding of US/EU regulatory requirements
Demonstrated experience of leading successful engagement with FDA and 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 (~20%)

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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