Associate Director, Regulatory Affairs
Department: 130 RegulatoryLocation: Waltham, MA
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
The Associate Director, Regulatory Affairs will help drive forward our regulatory strategy and operational activities related to Dyne’s muscle disease programs. A successful candidate must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases is a must.
Primary Responsibilities Include:
- Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings.
- As a member of study team, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.
- Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.
- Manage timelines and support preparation of meeting requests and briefing documents.
- Author/edit documents to support regulatory submissions.
- Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
- Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
- Support the organization with health authority meetings.
- Provide strategic guidance for and author applications related to expedited programs/designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc).
- Manage staff and vendors as needed to support regulatory activities.
- Assist with SOP generation.
- Perform other duties as required, interfacing with other departments, CROs and external vendors as needed
Education, Knowledge & Skill Requirements
- Minimum of a bachelor’s degree in life science or related discipline is required
- Minimum of 5-8 years of experience in regulatory strategy
- Strong experience with CTD format and content regulatory filings
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
- Experience in Health Authority Meetings
- Knowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plus
- Ability to work independently to manage multiple projects in a fast-paced environment
- Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
- Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Project Teams and senior management
- Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned
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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.
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