Director, Regulatory Affairs Project Manager

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Job description

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).

Role Summary:

The Regulatory Affairs Project Manager is an experienced project manager who works closely with the Global Regulatory Affairs, Regulatory Operations, and cross-functional teams to facilitate timely submission of high-quality data packages to US and international health authorities. This role provides support to these teams, tracks and coordinates cross-functional deliverables for regulatory timelines supporting regulatory submissions including market applications. This position can be a full-time employee or on a contract-based position.

This role is based in Waltham, MA without the possibility of being fully remote.

Primary Responsibilities Include:

• Develop and maintain overall integrated project timelines, specifically including BLA/MAA and other marketing application timelines
• Develop and maintain dashboards to identify and monitor critical items in preparation of global filings
• Provide project management support to the global Regulatory team for key agency interactions
• Support CMC Regulatory in development of timelines to support submission amendments
• Proactively identify potential issues, constraints, bottlenecks, risks, and mitigation management and escalates issues, as needed; propose solutions to support decision-making
• Communicate with leadership and program teams in a concise and timely manner

Education and Skills Requirements:

• Bachelor's degree in scientific field preferred with at least 10 years' experience in biotechnology or pharmaceutical industry
• Demonstrated project management skills with demonstrated ability to prioritize multiple projects
• Experience developing project plans and content plans and other filing to
• Prior experience as lead project manager for BLA or NDA; understanding of must-haves vs. nice-to-haves for regulatory filings
• Strong technical system proficiencies particularly Smartsheet, MS Project, Visio and Excel, Veeva, SharePoint
• Excellent organizational and meeting management/facilitation skills
• Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels
• Excellent written and verbal communication skills, including negotiation skills, with the ability to communicate at all levels of the organization
• Persuasively convey ideas and suggestions for forward momentum
• Skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies
• Comfortable with negotiation and challenging the status quo to bring forward innovative solutions
• Strong attention to detail with the propensity to document at the right level
• Ability to identify roadblocks and provide direction to teams to explore alternative solutions or paths

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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