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Senior Director, Regulatory Affairs – Europe

Department: 130 Regulatory

Location: Europe

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 seen with other approaches. Dyne has a broad portfolio of programs for serious muscle diseases, including candidates for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on TwitterLinkedIn and Facebook.

Role Summary:

The Senior Director, Regulatory Affairs Europe will partner with our Global Regulatory Affairs Program Leads to provide regulatory guidance and tactical support to further the progress of our development programs. This role will bring additional depth and breadth in ex-US regulatory operations to our Global Regulatory team to translate regulatory, scientific, operational, and business knowledge into effective implementation plans. The person in this role will play a major role in shaping cohesive regulatory strategy across Dyne’s programs and ensuring effective integration of broad regulatory tactics supporting the overall global strategy.

Primary Responsibilities Include:

  • Partner with the Global Regulatory Program Leads to support the creation and execution of the ex-US regulatory strategy, including for regulatory submission documents and health authority communications
  • Provide global regulatory support, advice and guidance to projects, including preparation for meetings with ex-US regulatory authorities
  • 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
  • Partner on the development and management of ex-US Regulatory plans and timelines
  • Work to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations
  • Remain up to date on changing ex-US regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy
  • Drive and align the with the Global Regulatory Leads on the Global Regulatory Strategic initiatives
  • Define, map, implement, and track progress of ex-US regulatory strategy initiatives
  • Partner with regulators and influence content of emerging regulatory guidance
  • Ensure appropriate ex-US regulatory input is provided into global regulatory plans
  • Oversee and provide input to global roadmaps and gap analysis
  • Influence and help shape the EU External regulatory landscape
  • Build networks and relationships with key stakeholders including regulatory agencies
  • 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
  • Support preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements
  • Author/edit documents to support regulatory submissions
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements
  • Manage vendors as needed to support regulatory activities
  • Assist with SOP generation

Education and Skill Requirements:

  • Bachelor’s degree, or master’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
  • Extensive knowledge of regulatory affairs and global development in rare disease
  • Experience in leading major interactions with ex-US health authorities
  • Understand the drug development process and strategies for development programs
  • Critical thinking on current global regulatory questions with knowledge of corresponding scientific components
  • In depth experience with and knowledge of European Regulations
  • Proven experience of defining and leading innovative regulatory strategies to advance novel therapies
  • Experience working with novel regulatory pathways is advantageous
  • Strong experience with CTD format and content regulatory filings
  • Experience leading Health Authority Meetings
  • A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
  • 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
  • Ability to provide regulatory leadership on a cross-functional teams and work effectively in a matrix environment
  • Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments
  • Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development
  • Ability to articulate the organization’s strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs and initiatives
  • Ability to work independently to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones
  • Outstanding communication skills (verbal and written), regulatory writing skills and willingness to share knowledge and lessons learned
  • Must thrive working in a fast-paced environment, where fearless innovation is a core value
  • Ability to clearly communicate and to resolve complex issues and mitigate risks
  • Embrace our core values
  • Excitement about the vision and mission of Dyne

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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