Dyne Therapeutics · 13 hours ago
Associate Director, Regulatory CMC
Waltham, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$159K/yr - $195K/yr
7+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Associate Director, Regulatory CMC is accountable for executing global CMC regulatory strategies for programs in early and late-stage development, partnering with various teams to support clinical registration and manufacturing efforts.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Lead CMC Regulatory execution for specific programs at all stages of development
Provide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirements
Serve as a CMC strategist and project leader for projects, providing regulatory assessments and developing regulatory strategies with input and guidance from the team and leadership
Lead the development of CMC documentation pertaining to global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests with authoring support from Manufacturing and Quality team members, including amendments to clinical and commercial manufacturing changes
Responsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activities
Leverage both technical and regulatory knowledge to proactively mitigate risks
Serves as the Regulatory Affairs CMC representative in functional and team meetings
Act as point of contact to cross-functional teams on global Regulatory CMC project/program issues
Execute regulatory policies and operational processes to deliver high quality regulatory submissions
Qualification
Required
Minimum of a bachelor's degree in life science or related discipline
Minimum of 7 years of experience in the biotech/pharmaceutical industry
Minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
Solid understanding of FDA regulatory guidance, ICH guidelines
Strong experience with CTD format and content of regulatory filings
Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
Ability to work independently to manage multiple projects in a fast-paced environment
Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program's critical regulatory milestones
Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management
Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detail
Recognized as a leader, team player, and possess a cross-functional collaborative skill set
Ability to influence without authority
Positive team member who embodies the Dyne Core Values
Excitement about Dyne's vision and mission
Preferred
Experience in Rare Disease
Experience leading and developing CMC sections of Biologics marketing applications
Knowledge of EU and international regulations related to clinical and nonclinical development
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
MarketScreener
2025-12-24
2025-12-24
Company data provided by crunchbase