Associate Director, Regulatory CMC

Role Summary

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports Dyne’s clinical registration, commercial development, and manufacturing efforts, as applicable. This position partners with the manufacturing team, clinical operations, quality, other regulatory team members, and program teams.

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

Qualifications

• Required: Minimum of a bachelor’s degree in life science or related discipline
• Required: Minimum of 7 years of experience in the biotech/pharmaceutical industry, and a minimum of 5 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
• Preferred: Experience in Rare Disease
• Preferred: Experience leading and developing CMC sections of Biologics marketing applications
• Required: Solid understanding of FDA regulatory guidance, ICH guidelines
• Required: Strong experience with CTD format and content of regulatory filings
• Required: Thorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trends
• Preferred: Knowledge of EU and international regulations related to clinical and nonclinical development
• Required: Ability to work independently to manage multiple projects in a fast-paced environment
• Required: Ability to effectively collaborate in a dynamic, cross-functional environment to meet each program’s critical regulatory milestones
• Required: Ability to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior management
• Required: Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge with strong attention to detail
• Required: Recognized as a leader, team player, and possess a cross-functional collaborative skill set
• Required: Ability to influence without authority
• Required: Positive team member who embodies the Dyne Core Values
• Required: Excitement about Dyne’s vision and mission

Skills

• Regulatory writing and CTD composition
• Cross-functional collaboration and program leadership
• Strategic regulatory thinking and risk mitigation
• Excellent verbal and written communication
• Project management and ability to manage multiple programs simultaneously

Education

• Bachelor’s degree in life science or related discipline (required)