Associate Director Regulatory Chemistry Manufacturing and Control
12 hours ago
The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.
Key Responsibilities:- Lead CMC regulatory execution for specific programs at all stages of development, ensuring compliance with global regulatory requirements.
- Provide strategic Regulatory input to the Manufacturing and Quality organizations, guiding global product development requirements.
- Serve as a CMC strategist and project leader, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
- Lead the development of CMC documentation for global Regulatory filings (IND, IMPD, BLA, etc.) and responses to Health Authority requests, with authoring support from Manufacturing and Quality team members.
- Coordinate and manage global submissions, maintain product compliance, and manage change control related activities.
- Leverage technical and regulatory knowledge to mitigate risks and ensure regulatory compliance.
- Serve as the Regulatory Affairs CMC representative in functional meetings and act as the point of contact for cross-functional teams on global Regulatory CMC project/program issues.
- Execute regulatory policies and operational processes, delivering high-quality regulatory submissions.
- Act as the company liaison on CMC Regulatory matters, supporting related meetings, including preparation of briefing books, training, and preparing the technical team.
- Minimum of a bachelor's degree in life science or related discipline.
- Minimum of 7 years of experience in the biotech/pharmaceutical industry, with a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company.
- Experience leading and developing CMC sections of marketing applications is preferred.
- Experience in Rare Disease is preferred.
- Understanding of FDA regulatory guidance, ICH guidelines, and CTD format and content of regulatory filings is required.
- Strong experience with biologics and thorough understanding of the drug development process and pharmaceutical industry, including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends.
- Knowledge of EU and international regulations related to clinical and nonclinical development is a plus.
- Ability to work independently to manage multiple projects in a fast-paced environment and 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, regulatory writing skills, and willingness to share knowledge and lessons learned with strong attention to detail.
- Ability to interact effectively and influence across relevant functions within Dyne and with regulators.
- Recognized as a leader, team player, and possess a cross-functional collaborative skill set.
- Ability to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and priorities.
- Embrace Dyne's core values and culture.
- Excitement about the vision and mission of Dyne.
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Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Chemistry Manufacturing and ControlThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics Inc, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
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