Associate Director, Regulatory CMC

BioSpace · Waltham, MA · 3 wk ago

On-siteBusiness Development$159k–$195k/yrFull-time

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 role is based in Waltham, MA.

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, 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

Education and Skills Requirements

Minimum of a bachelor’s degree in life science or related discipline is 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
Experience in Rare Disease preferred
Experience leading and developing CMC sections of Biologics marketing applications preferred
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
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
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

Company

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).

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