New · posted Oct 15
Scholar Rock · Biotechnology
Associate Director, Regulatory Strategy
- Cambridge, MA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
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
- 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%)
What you'll do
- 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
Pay
$175,000 – $225,000 a year
Employer providedWhere you'll work
Cambridge, MAHybridOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAEqual 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 15% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts27 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $175,000 | — | $225,000 |
| Massachusetts (middle half) | $207,500 | $232,500 | $264,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
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.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Regulatory submissions5
- GMP and compliance2
- Documentation and SOPs2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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%
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Associate Director, Regulatory Strategy at Scholar Rock
Open until filled. $175K–$225K a year, employer provided.