What are the responsibilities and job description for the Executive Director, EU Regulatory Affairs position at Dyne Tx?
Our commitment to people with muscle diseases is our greatest strength.
Please ensure you read the below overview and requirements for this employment opportunity completely.
Executive Director, EU Regulatory Affairs
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 our website.
Role Summary :
The Executive Director, EU Regulatory Affairs is responsible for the planning, management, support, and execution of regulatory activities for Dyne product candidates covering Europe / UK / Switzerland by partnering with Global Regulatory Affairs program leads and other key functional stakeholders. The Executive Director works closely with the Vice President in ensuring that EU regulatory strategies are executed in compliance with the current, applicable regulations and standards. The person in this role must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, good conflict management, and negotiation skills. A shared passion for Dyne’s mission to bring transformative therapies to people living with serious muscle diseases is a must.
Primary Responsibilities Include :
- Partner with the Global Regulatory Program Leads / Strategists to lead the creation and execution of regulatory strategies including authoring regulatory submission documents where needed to support timely regulatory filings in the assigned regions.
- Compile / review / approve and submit clinical trial, orphan drug designation, PRIME, marketing authorization application and its life cycle management as needed.
- Manage staff and vendors as needed to support regulatory activities.
- Partner in leading interactions and negotiations with regulatory agencies in the assigned regions in coordination with internal resources and external vendors / consultants.
- Provide regulatory advice and guidance to projects covering the assigned regions in ensuring successful regulatory filings and approvals.
- Oversee preparation, review and submission of cross-functional documents supporting regulatory submissions.
- Manage timelines and preparation of meeting requests and briefing books for meetings with Health Authorities in the assigned regions.
- Address complex issues, providing advanced regulatory solutions and guidance to the global regulatory team and align communication to and from cross-functional teams and leadership.
- Remain up to date on regulations, policy and intelligence including competitive issues that influence regulatory strategy covering the assigned regions.
- Identify opportunities to streamline regulatory processes and systems by partnering with the Global Regulatory Leadership team where required.
- Ensure appropriate regulatory input is provided into global regulatory plans and initiatives covering the assigned regions.
- Oversee and provide input to EU roadmaps and gap analysis.
- Interpret the external regulatory environment and regulatory precedence for Dyne muscle disease programs.
- Create and lead forums for sharing of best practices and lessons learned related to European regulatory activities.
Education and Skills Requirements :
Based out of Europe (Netherlands / UK / Italy / Switzerland)
The statements contained herein reflect general details as necessary to describe the principal 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 construed 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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