Vice President, Head of Regulatory Strategy

Regulatory Toolkit; Cambridge (MA); On-site; USD 350,000 - 590,000; Full time

Job summary

Scholar Rock in Cambridge, MA seeks a Vice President, Head of Regulatory Strategy to build and lead the Global Regulatory Strategy team, shaping global regulatory plan across the portfolio and guiding program strategies through risk assessment and opportunities.

The role requires leading regulatory interactions with FDA/EMA, directing submissions, and partnering with cross-functional teams to align regulatory plans with clinical development and market access, with travel around 20%.

Qualifications

• Education in life sciences required.
• Based in Greater Boston; regular presence in Cambridge, MA office.
• 15+ years of Regulatory Affairs experience in biopharma with US/EU knowledge.
• Proven track record leading FDA/EMA engagements; strong leadership skills.
• Willingness to travel up to ~20% domestically and internationally.

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 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.
• 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

Skills

Regulatory leadership

FDA/EMA engagement

Communication skills

Biologics expertise

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 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