Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Associate Director, Regulatory Strategy

Full-time

scholarrock

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.

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Associate Director, Regulatory Strategy in Cambridge, MA vacancy
  •  ...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... 
    Suggested
    Shift work

    Scholar Rock

    Cambridge, MA
    5 days ago
  • $160.8k - $201k

     ...Support for Caregivers For a full list of our comprehensive benefits, see our website: The Importance of the Role The Associate Director, Corporate Strategy is an intense and important role helping Sarepta deliver on key corporate initiatives. The role will operate within... 
    Suggested

    Sarepta Therapeutics

    Cambridge, MA
    3 days ago
  • $100k - $150k

     ...stages of maturity. Some are the industry standard, some are starting off. There is a lot to learn, there is room to grow. Our Strategy function is responsible for the success of our products in the market; that\'s from guiding the product to client success. Today,... 
    Suggested
    Work experience placement
    Work at office
    Local area
    Work from home
    Flexible hours

    Veeva Systems

    Boston, MA
    1 day ago
  • $177k - $278.08k

     ...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of... 
    Suggested
    Minimum wage
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    2 days ago
  • $232k - $348k

    Job DescriptionThe Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy...  ...industry/agency regulatory meeting, committees and trade associations. Remains up to date on changing regulations, and... 
    Suggested
    Full time
    Summer work
    Work at office
    Local area
    Remote work
    Flexible hours
    2 days per week
    3 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $196.7k - $353.4k

    The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters or one of Moderna’s East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Somerville, MA
    3 days ago
  • $143k - $233k

    As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal supervision, accountable for developing and leading... 

    Relay Therapeutics

    Somerville, MA
    4 days ago
  • $170k - $195k

     ...What's the opportunity? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and...  ...development and implementation of a consolidated regulatory strategy (including Regulatory Operations) to help secure and... 
    Work experience placement
    Shift work

    Parabilis Medicines

    Cambridge, MA
    more than 2 months ago
  • $154.4k - $242.55k

     ...information I submit in my employment application is true to the best of my knowledge.Job DescriptionJoin Takeda as Associate Director, Consumer Omnichannel Strategy, Psoriatic Arthritis of our Cambridge, MA office. The Associate Director, Consumer Omnichannel Strategy,... 
    Minimum wage
    Work at office
    Local area
    Remote work

    Takeda

    Cambridge, MA
    1 day ago
  • $148.5k - $214.5k

    Job Title: Associate Director, General Medicines Access Strategy, Insulins Location: Morristown, NJ or Cambridge, MAAbout the JobThe Associate Director, Access...  ...thinking abilityUnderstanding of the legal/regulatory environment and internal Sanofi legal/regulatory guidelines... 
    Full time
    Contract work
    Temporary work
    Home office

    Sanofi

    Cambridge, MA
    3 days ago
  •  ...Fair360 and others. If you're as passionate about your future as we are, join our team.KPMG is currently seeking an Associate Director, Corporate Strategy to join our Corporate Strategy organization.Responsibilities:Support first-principles thinking to define firm-level... 
    H1b
    Local area
    Shift work

    KPMG

    Boston, MA
    3 days ago
  • ## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime type: Full timeposted on: Posted Todayjob...  ...to devise and implement innovative Regulatory strategies where little precedent exists. You will work in close collaboration... 
    Contract work
    Remote work

    Crispr Therapeutics AG

    Boston, MA
    10 hours ago
  • $224.9k - $404.6k

     ...opportunity to provide senior strategic leadership for global regulatory strategies supporting select early Oncology and Therapeutics programs,...  ....Anticipate and navigate complex regulatory challenges associated with innovative therapeutic modalities, including mRNA-based... 
    Permanent employment
    Full time
    Work at office
    Work from home

    Moderna Therapeutics

    Somerville, MA
    4 days ago
  • $268.2k - $402.2k

    Job DescriptionGeneral Summary:The Executive Director, Regulatory Strategy will serve as a seasoned regulatory leader with expert technical and tactical regulatory knowledge and advanced drug development expertise in Type 1 Diabetes (T1D). The incumbent will be responsible... 
    Full time
    Summer work
    Local area
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  • $164k - $246k

    Job DescriptionThe Associate Director, Regulatory Technology is accountable for translating Regulatory priorities into an actionable technology roadmap...  ...with Regulatory priorities and the broader technology strategy.Lead the end-to-end demand intake and prioritization... 
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • $154.4k - $242.55k

     ...a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory...  ...Oncology, you will define and lead global regulatory strategies for oncology programs, oversee major submissions, and... 
    Minimum wage
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    1 day ago
  • $154.4k - $242.55k

     ...information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda is hiring 3Associate Directors, HCP Branded Strategy and Marketing, Rheumatology located in Cambridge, MA. In these roles, you will be a champion of Takeda’s culture and... 
    Minimum wage
    Local area

    Takeda

    Somerville, MA
    3 days ago
  • $148.5k - $214.5k

    Job Title: Associate Director, Media Strategy & Planning Location: Cambridge, MAAbout the JobThe Go-to-Market Capabilities (GTMC) organization is designed to drive best-in-class capabilities across Sanofi, bringing value and excellence to our commercial operations through... 
    Full time

    Sanofi

    Cambridge, MA
    3 days ago
  • $154.4k - $242.55k

     ...information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the Role:As the Associate Director of HCP Branded Strategy and Marketing, you will be a champion of Takeda’s culture and values while leading the HCP branded strategy for... 
    Minimum wage
    Fixed term contract
    Term time
    Local area
    Remote work

    Takeda

    Cambridge, MA
    2 days ago
  • $170.9k - $231.3k

    OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for development-stage programs. This role will play a critical part in shaping regulatory strategies for emerging therapeutic... 
    Full time
    Temporary work
    Work at office
    Local area
    Flexible hours

    Alnylam Pharmaceuticals

    Somerville, MA
    10 hours ago
  • $142.5k - $256.5k

     ...radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management &...  ...defining and advancing Moderna’s regulatory data strategy, governance framework, and digital data ecosystem... 
    Permanent employment
    Full time
    For contractors
    Work at office
    Work from home

    Moderna Therapeutics

    Somerville, MA
    4 days ago
  • $170.9k - $231.3k

    OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data... 
    Full time
    Temporary work
    Local area
    Worldwide
    Flexible hours
    2 days per week

    Alnylam Pharmaceuticals

    Somerville, MA
    10 hours ago
  • $154.4k - $242.55k

     ...and tactical guidance to teams for the delivery of global regulatory strategies to support development and commercialization of biomarkers,...  ...drafting and reviewing guidance comments and supporting trade association working groups.Education & Competencies (Technical and... 
    Minimum wage
    Local area
    Remote work

    Takeda

    Boston, MA
    2 days ago
  • $150k - $214k

    The Opportunity Reporting to the Executive Director, Head of Regulatory Project Management, you will support the planning, coordination, and execution...  ...leaders and cross-functional teams, ensuring regulatory strategies are translated into integrated, actionable plans that... 
    Work at office

    Relay Therapeutics

    Cambridge, MA
    1 day ago
  • $154.4k - $242.55k

     ...therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and...  ...regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory... 
    Minimum wage
    Local area
    Remote work
    Worldwide

    Takeda

    Boston, MA
    2 days ago
  • $166.4k - $249.6k

    Job DescriptionGeneral Summary:The Chemistry Manufacturing Controls Associate Director executes multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages... 
    Full time
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    2 days ago
  • $120k - $200k

    The Opportunity:As the Senior Associate/Associate Director of Portfolio and Strategy Operations, you will help ensure flawless operation of activities for a first-in-class program as it moves through clinical development while reporting to the Director of Portfolio Strategy... 
    Flexible hours

    Relay Therapeutics

    Somerville, MA
    1 day ago
  • $184k - $276k

     ...United States; Reno, NV, United StatesWorkplace: HybridSchedule: Full timePosted: 2026-11-04Grant Thornton is seeking an Associate Director, Strategy & Operations to join the team. Approved office locations can be found below. Position Summary:The Associate Director,... 
    Internship
    Seasonal work
    Work at office
    Local area
    Flexible hours
    3 days per week

    Grant Thornton

    Boston, MA
    3 days ago
  • $79.56k - $115.72k

     ...competitive salaries, and a hybrid flexible work schedule. The Associate Director of Development plays an integral role in strengthening the...  ...as established by the department. PORTFOLIO (90%) Develop strategies, goals and objectives for the cultivation, solicitation and... 
    Temporary work
    Work at office
    Remote work
    Flexible hours
    Shift work

    Brigham and Women's Hospital

    Somerville, MA
    1 day ago
  • $175k - $200k

     ...Associate Director, Financial Planning & Analysis (FP&A)Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable... 

    Parabilis Medicines

    Cambridge, MA
    10 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, Regulatory Strategy. Be the first to apply!