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Executive Director, Regulatory Affairs at Dyne Therapeutics — BranchFactor

Shape and lead comprehensive global regulatory strategy for a Dyne program, driving long-term vision that aligns with corporate, functional, and program objectives and advances patient-focused mission
Contribute to functional strategy by collaborating to establish mid-term goals, setting strategic priorities, and ensuring execution aligns with financial performance targets and organizational objectives
Provide strategic oversight of regulatory function for a program through functional managers and leaders, setting the tone for emotionally intelligent, feedback-driven leadership across the organization
Partner with executive stakeholders to negotiate and influence critical regulatory matters affecting the entire organization, building trust through transparent communication and inclusion
Develop and execute corporate regulatory policies that influence organizational direction, ensuring alignment with delivering meaningful outcomes for patients
Lead interactions with global health authorities including FDA, EMA, and other regulatory agencies, representing the company at critical strategic meetings and shaping regulatory pathway decisions
Ensure compliance with regulatory requirements throughout the product lifecycle
Oversee preparation and submission of major regulatory filings including INDs, CTAs, NDAs, BLAs, and MAAs, maintaining compliance with all regulatory requirements
Direct regulatory program strategy for expedited programs and designations for rare muscle diseases, including Fast Track, Orphan Drug Designation, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy designations
Foster innovation and bold thinking across the regulatory team by leveraging deep company knowledge, guiding functional leaders in embedding purpose, accountability, and emotional intelligence into operations
Lead talent development initiatives, mentoring senior regulatory professionals and building organizational capability to support long-term growth and sustained high performance
Exercise judgment in contributing to corporate strategy, addressing complex and intangible organizational challenges related to regulatory science and policy
Interact internally and externally with executive stakeholders across the organization, negotiating and influencing critical matters that affect the entire enterprise
Contribute to strategic direction for the regulatory function and influences enterprise-wide initiatives, building trust through transparent communication, empowerment, and inclusion while modeling high standards of leadership across the company
Leverage deep company knowledge to foster innovation, guide functional managers and leaders in embedding purpose, accountability, and emotional intelligence into operations, and model Dyne's values through leading with commitment and resolve
Exercise judgment in setting and contributing to program and functional strategy, establishes mid-term goals, sets priorities, and ensures execution aligns with corporate objectives and financial performance targets
Monitor global regulatory trends and provide strategic guidance to senior leadership
Embed Dyne's values into long-term people strategies, and ensure accountability, talent development, and organization-wide alignment
Encompass broad decision-making latitude in addressing complex organizational challenges, anticipating regulatory risks and opportunities, and making decisions that influence department-wide direction and enterprise strategy
Lead regulatory inspections and audits and ensure corrective actions are implemented promptly
Develop and mentor the regulatory affairs team on best practices and regulatory changes
Collaborate cross-functionally for successful product development and launch

Executive Director, Regulatory Affairs

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