Executive Director, EU Regulatory Affairs

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, 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. This role supports regulatory interactions with Regulatory agencies on behalf of the company, and involves the ability to develop regulatory strategy as well as requires hands on responsibilities.

Primary Responsibilities Include:

• Partner with the Global Regulatory Program Leads/Strategists to lead the creation and execution of the 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.
• Partners 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:

• Bachelor’s or Master’s degree in life science or related discipline plus minimum 12 years of experience is required
• Recent hands-on experience with the Centralized Registration Procedure.
• Demonstrated, hands-on experience with leading, managing and preparing EU regulatory submissions including PIP, ODD, PRIME, scientific advice and marketing authorization applications.
• Experience of managing Clinical Trial Applications.
• Experience of building relationships with regional and/or national health authorities, particularly in situations requiring direct interaction/negotiation.
• In depth experience with and knowledge of European Regulations.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Proven experience of defining and leading innovative regulatory strategies to advance novel therapies.
• Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents.
• Proven interpersonal skills, and the ability to develop important relationships with key stakeholders.
• Ability to provide regulatory leadership on a cross-functional teams and work effectively in a matrix environment.
• Ability to clearly communicate and to resolve complex issues and mitigate risks.
• Embrace our core values.
• Excitement about the vision and mission of Dyne.

Based out of Europe (Netherlands/UK/Italy/Switzerland)