Director, Regulatory Affairs
2 weeks 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 Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs. The person in this role 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.
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:
As a member of program teams, 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 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 8-10 years of experience in regulatory strategy in a clinical-stage biotechnology company
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 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
#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.
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