Current jobs related to Associate Director, Regulatory Affairs CMC - Waltham, Massachusetts - Dyne Therapeutics
-
Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Associate Director, Regulatory Affairs CMCDyne Therapeutics Inc is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. As a key member of our Regulatory Affairs department, you will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond...
-
Associate Director Regulatory Affairs CMC
2 weeks ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Associate Director, Regulatory Affairs CMCJob Summary:Dyne Therapeutics is seeking an experienced Associate Director, Regulatory Affairs CMC to join our team. The successful candidate will be responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key...
-
Associate Director Regulatory Affairs CMC
1 week ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory Affairs CMCCompany 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 FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to...
-
Associate Director Regulatory Affairs CMC
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryDyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are seeking an experienced Associate Director, Regulatory Affairs CMC to join our team.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all...
-
Waltham, Massachusetts, United States Alkermes Full timeJob Description Overview: Alkermes is a global biopharmaceutical company dedicated to developing innovative treatments for complex and difficult-to-treat psychiatric and neurological disorders. We are seeking an experienced Associate Director of CMC Regulatory Affairs to join our team in Waltham, MA. Key Responsibilities:Develop and lead regulatory CMC...
-
Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) plays a pivotal role in 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...
-
Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob Title: Associate Director, Regulatory CMCThe Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is a critical role at Dyne Therapeutics, 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...
-
Regulatory Affairs Director
1 month ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeJob SummaryThe Associate Director, Regulatory Affairs CMC is a critical role at Dyne Therapeutics, responsible for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval.Key ResponsibilitiesLead CMC regulatory execution for specific programs at all stages of developmentProvide strategic...
-
Associate Director, Regulatory Affairs
2 weeks ago
Waltham, Massachusetts, United States Alkermes Full timeJob DescriptionOverview:At Alkermes, we are committed to developing medicines that address unmet patient needs. As an Associate Director of CMC Regulatory Affairs, you will play a critical role in supporting post-approval CMC changes and global Supply Chain and GMP activities for our marketed products.Key Responsibilities:Develop and lead regulatory CMC...
-
Waltham, Massachusetts, United States Alkermes Full timeJob SummaryAlkermes is seeking a highly skilled Associate Director to lead our Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory strategies and guidance on post-approval CMC topics.Key ResponsibilitiesDevelop and lead regulatory CMC...
-
Regulatory CMC Senior Manager
3 days ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob DescriptionDeciphera Pharmaceuticals, a biopharmaceutical company, is seeking a highly skilled Regulatory CMC Senior Manager to join its growing Post-Approval Group within the Regulatory Affairs Organization. The primary responsibility of this position is to lead and execute post-approval CMC regulatory activities in support of Deciphera's globally...
-
Regulatory CMC Director
2 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeJob Title: Associate Director/Director, Regulatory CMCAt Upstream Bio, we are seeking an experienced Associate Director/Director, Regulatory CMC to lead our regulatory Chemistry, Manufacturing, and Controls (CMC) strategy for our biopharmaceutical products. This role involves collaborating with cross-functional teams to ensure compliance with global...
-
Regulatory CMC Director
4 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeJob Title: Associate Director/Director, Regulatory CMCUpstream Bio is a pioneering biopharmaceutical company dedicated to developing innovative therapeutics in inflammation. With a strong financial backing and a team of experts, we are pushing the boundaries of science to create life-changing treatments. Our focus is on two Phase 2 studies in asthma and...
-
Regulatory CMC Director
4 weeks ago
Waltham, Massachusetts, United States Upstream Bio Full timeJob Title: Associate Director/Director, Regulatory CMCUpstream Bio is a pioneering biotech company dedicated to developing innovative therapeutics for inflammation. With a strong financial backing and a team of experts, we are pushing the boundaries of monoclonal antibody development. Our focus is on two Phase 2 studies in asthma and chronic rhinosinusitis...
-
Regulatory Affairs Director
7 days ago
Waltham, Massachusetts, United States BioSpace, Inc. Full timeJob Title: Regulatory Affairs DirectorAt Dyne Therapeutics, we are seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory strategy team, you will be responsible for driving forward our regulatory strategy and operational activities related to our muscle disease programs.The ideal candidate will have a strong...
-
Regulatory Affairs Director
4 weeks ago
Waltham, Massachusetts, United States Taylor Strategy Partners Full timeJob Title: Director, Regulatory Affairs Job Summary: We are seeking a highly experienced Director, Regulatory Affairs to lead our regulatory strategy and operations. As a key member of our team, you will be responsible for developing and implementing a consolidated regulatory strategy to secure and maintain market access for our products. Key...
-
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...
-
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...
-
Regulatory Affairs Director
2 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Inc Full timeJob Title: Regulatory Affairs DirectorDyne Therapeutics Inc is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing our regulatory strategy to ensure compliance with regulatory requirements.Key Responsibilities:Develop and implement regulatory...
-
Regulatory Affairs Manager
2 weeks ago
Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full timeJob SummaryDeciphera Pharmaceuticals is seeking a highly skilled Manager/Senior Manager, Regulatory CMC to join our Post-Approval Group within the Regulatory Affairs Organization. This role will lead, contribute, and execute on post-approval CMC regulatory activities in support of our globally approved marketing applications.The ideal candidate will have 6+...
Associate Director, Regulatory Affairs CMC
3 months ago
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 FORCETM 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).
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:
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 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 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
#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.
