Dyne Therapeutics Inc
Associate Director, Regulatory Affairs CMC
Dyne Therapeutics Inc, Waltham, Massachusetts, United States, 02254
Company Overview:
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). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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. The position reports to the Executive Director, Regulatory Affairs CMC.
This role is based in Waltham, MA without the possibility of being a remote role.Primary Responsibilities Include:Lead CMC regulatory execution for specific programs at all stages of developmentProvide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirementsServe 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 changesResponsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activitiesLeverage both technical and regulatory knowledge to mitigate risksServes as the Regulatory Affairs CMC representative in functional meetingsAct as point of contact to cross-functional teams on global Regulatory CMC project/program issuesExecute regulatory policies and operational processes and deliver high quality regulatory submissionsAct as the company liaison on CMC Regulatory matters and support related meetings, including preparation of briefing books, training, and preparing the technical teamEducation, Knowledge & Skill Requirements
Minimum of a bachelor's degree in life science or related discipline is requiredMinimum 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 companyExperience leading and developing CMC sections of marketing applications preferredExperience in Rare Disease preferredUnderstanding of FDA regulatory guidance, ICH guidelinesStrong experience with CTD format and content of regulatory filings. Biologics experience is preferredThorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trendsKnowledge of EU and international regulations related to clinical and nonclinical, development a plusAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate in a dynamic, cross-functional environment to meet each program's critical regulatory milestonesAbility to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior managementOutstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detailAbility to interact effectively and influence across relevant functions within Dyne and with regulatorsRecognized as a leader, team player, and possess a cross-functional collaborative skill setAbility to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and prioritiesEmbrace Dyne's core values and cultureExcitement about the vision and mission of Dyne
#LI-Onsite
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.
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). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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. The position reports to the Executive Director, Regulatory Affairs CMC.
This role is based in Waltham, MA without the possibility of being a remote role.Primary Responsibilities Include:Lead CMC regulatory execution for specific programs at all stages of developmentProvide strategic Regulatory input to the Manufacturing and Quality organizations pertaining to global product development requirementsServe 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 changesResponsible for the coordination and management of global submissions, maintenance of product compliance, and management of change control related activitiesLeverage both technical and regulatory knowledge to mitigate risksServes as the Regulatory Affairs CMC representative in functional meetingsAct as point of contact to cross-functional teams on global Regulatory CMC project/program issuesExecute regulatory policies and operational processes and deliver high quality regulatory submissionsAct as the company liaison on CMC Regulatory matters and support related meetings, including preparation of briefing books, training, and preparing the technical teamEducation, Knowledge & Skill Requirements
Minimum of a bachelor's degree in life science or related discipline is requiredMinimum 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 companyExperience leading and developing CMC sections of marketing applications preferredExperience in Rare Disease preferredUnderstanding of FDA regulatory guidance, ICH guidelinesStrong experience with CTD format and content of regulatory filings. Biologics experience is preferredThorough understanding of drug development process and the pharmaceutical industry including global regulatory CMC requirements, guidance, accelerated regulatory review paths, and policy trendsKnowledge of EU and international regulations related to clinical and nonclinical, development a plusAbility to work independently to manage multiple projects in a fast-paced environmentAbility to effectively collaborate in a dynamic, cross-functional environment to meet each program's critical regulatory milestonesAbility to effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project/Program Teams and senior managementOutstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned with strong attention to detailAbility to interact effectively and influence across relevant functions within Dyne and with regulatorsRecognized as a leader, team player, and possess a cross-functional collaborative skill setAbility to drive timelines, meet firm deadlines, and adapt quickly to changing requirements and prioritiesEmbrace Dyne's core values and cultureExcitement about the vision and mission of Dyne
#LI-Onsite
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.