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New · posted Oct 15

Scholar Rock · Biotechnology

Vice President, Head of Regulatory Strategy

  • Cambridge, MA
  • Hybrid
  • Full-time
  • VP & Executive
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Pay$305K–$360Ka year · employer provided
EmploymentFull-time
LocationCambridge, MAHybrid
LevelVP & Executive
FunctionRegulatory AffairsRegulatory
Deadline

Open until filled

The role

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.

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.

What you need

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%)

    • Skills named in this posting

    What you'll do

  • 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

    • Pay

    $305,000 – $360,000 a year

    Employer provided
    How this compares

    Where you'll work

    Cambridge, MAHybridOpen in Maps (opens in a new tab)

    More jobs in Cambridge, MA
    Equal opportunity, accessibility and legal noticesScholar Rock's statements, word for word

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

    Job intelligence

    The context around this role

    Live data · October 15, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 4% above the US median for Regulatory Affairs roles at this level.

    This roleEmployer provided

    $305,000 to $360,000 a year

    VP & Executive roles in Massachusetts5 roles publishing pay

    Middle half $309,000 to $325,000, median $313,000

    VP & Executive roles in the US15 roles publishing pay

    Middle half $305,750 to $362,250, median $320,500
    Annual base pay
    Annual base payLowMedianHigh
    This role$305,000—$360,000
    Massachusetts$309,000$313,000$325,000
    All US$305,750$320,500$362,250

    This role: Scholar Rock's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Regulatory Affairs

    The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Scholar Rock's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Regulatory Affairs Specialist · Summer 2027 Internship

      $90K median34 open

    2. Earlier

      Senior & Principal

      Often: Senior Regulatory Affairs Specialist · Principal Regulatory Affairs Specialist

      $138K median69 open

    3. Earlier

      Manager

      Often: Regulatory Affairs Manager · Manager, Regulatory Affairs

      $163K median59 open

    4. One step back

      Director

      Often: Director, Regulatory Affairs · Senior Director, Regulatory Affairs

      $235K median110 open

    5. This role

      VP & Executive

      Often: Vice President, Regulatory Affairs · Global Head of Injectable Aesthetics Regulatory Strategy

      $321K median18 open

    Career resources on Regulatory Affairs

    Skills DNA

    What this role leans on

    How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 1 lineDocumentation and SOPs: 1 lineRegulatory submissions: 2 linesCollaboration and leadership: 4 linesGMPDocumentationSubmissionsTeamwork
    • Collaboration and leadership4
    • Regulatory submissions2
    • GMP and compliance1
    • Documentation and SOPs1

    Company hiring pulse

    Scholar Rock on Regulatory Jobs

    4
    Open roles
    4
    Distinct roles
    1
    Locations

    By discipline

    • Regulatory2 50%
    • Quality2 50%

    By level

    • Director3 75%
    • VP & Executive1 25%
    See all 4 Scholar Rock roles

    More roles at Scholar Rock

    Similar Regulatory Affairs roles elsewhere

    Vice President, Head of Regulatory Strategy at Scholar Rock

    Open until filled. $305K–$360K a year, employer provided.

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      Vice President, Head of Regulatory Strategy at Scholar Rock — Cambridge, MA | Regulatory Jobs