Director, Regulatory Affairs CMC

Company Overview

Dyne Therapeutics is focused on discovering and advancing innovative life-transforming therapeutics for people living with genetically driven neuromuscular diseases. Leveraging the modularity of its FORCE™ platform, Dyne is developing targeted therapeutics that are designed to overcome limitations in delivery to muscle tissue and the central nervous system (CNS). Dyne has a broad pipeline for neuromuscular diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.

Role Summary

The 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.

This role is based in Waltham, MA without the possibility of being a fully remote role.

Primary Responsibilities Include

• 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/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC.
• 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. Includes 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 mitigate risks
• Serves as the Regulatory Affairs CMC representative in functional meetings
• Act as point of contact to cross-functional teams on global Regulatory CMC project/program issues
• Execute regulatory policies and operational processes and deliver high quality regulatory submissions
• Act as the company liaison on CMC Regulatory matters and support related meetings, including preparation of briefing books, training, and preparing the technical team
  
  
  

Education, Knowledge & Skill Requirements

• Minimum of a bachelor’s degree in life science or related discipline is required
• Minimum of 10 years of experience in the biotech/pharmaceutical industry with a minimum of 8 years in regulatory affairs in a clinical-stage and/or commercial biotechnology company
• Experience leading and developing CMC sections of marketing applications preferred
• Experience in Rare Disease preferred
• Understanding of FDA regulatory guidance, ICH guidelines
• Strong experience with CTD format and content of regulatory filings. Biologics experience is preferred
• Thorough understanding of drug development process and the 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 a plus
• 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
• 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
  
  
  

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.