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 SVP, Global Regulatory Affairs is responsible for leading, managing, and driving all aspects of the Regulatory Affairs function, including leading the Global Regulatory Strategy team. This role partners with the Chief Regulatory Affairs Officer (CRAO) and Global Regulatory Program Leads to develop and execute a consolidated Regulatory development strategy to support company goals. This position involves both high level strategic planning as well as hands-on responsibilities including reviewing of strategic regulatory documents used to support strategic regulatory discussions with global health authorities.
This role is based in Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
- Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations
- Responsible for managing the global regulatory strategy for the company's product pipeline and providing strategic leadership to oversee and direct all regulatory activities from early and late-stage development through post-approval activities
- Play a key role in review of regulatory documentation and ensure content is suitable for global regulatory submissions
- Oversee growth, and execution of the Regulatory function including ensuring that it serves the Dyne Program teams to support program team goals, function goals and milestones
- Serve as a critical member of the Dyne Senior Leadership team providing global product strategy, US regulatory framework knowledge, and leadership for external regulatory initiatives
- Partner effectively cross functionally (Preclinical, Clinical, Quality Program Management, CMC, Translational Medicine, and research) to accomplish strategic and operational goals and participates on cross-functional project teams representing Regulatory on an ongoing basis
- Partner with the management team to ensure strategic business goals are met through communication of the regulatory position on development products and presents to senior management governance committees as needed.
- Responsible for awareness and oversight of all regulatory requirements including authoring, cross functional review and submission of regulatory documents for products in clinical development, including all new and open INDs/CTAs, and other global submission documents in support of clinical trials and marketing applications.
- Partner in leading interactions and negotiations with regulatory agencies in the US and worldwide in coordination with internal resources and external vendors/consultants.
- Leverage expertise of US, EU and ICH regulatory requirements to apply to development programs
- Maintain up to date working knowledge of US laws, regulations, and guidelines as well as expertise with the global regulatory environment
- Ensure that the business needs for all programs are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all global regulatory requirements
- Ensures team appropriate training and regulatory compliance
- Evaluate labeling, advertising and promotion from the standpoint of compliance with applicable (e.g., FDA) rulings and policies
Education and Skills Requirements:
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience and at least twenty (20) years of progressively responsible experience in regulatory affairs within the biopharmaceutical industry, or equivalent. Minimum of 10-15 years of experience in a senior regulatory role
- Experience with filing Market Applications globally (ideally BLA, MAA)
- Experience with regulatory aspects of rare disease products
- Experience developing complex biologics products (ideally oligonucleotides)
- Ability to apply knowledge of FDA, EMA, and ICH guidelines both strategically and operationally
- Experience in the preparation and submission of regulatory documents
- Excellent working knowledge of drug development process and knowledge of regulatory requirements including US, EU and global regulatory experience
- Experience in a successful leadership role in managing a global team to develop and register candidate drugs through regulatory product approval and commercialization
- Proven ability to create a culture of performance and accountability
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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.
