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:

• Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings
• 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

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