Executive Director, Regulatory Affairs
Dyne Therapeutics
11 days ago
Remote friendly (Waltham, MA)
United States
Corporate Functions
Role Summary:
Executive Director, Regulatory Affairs. Based in Waltham, MA. Leads long-term regulatory strategy, oversees compliance across the product lifecycle, and drives regulatory functional direction and organizational alignment.
Primary Responsibilities:
- Shape and lead comprehensive global regulatory strategy for a Dyne program.
- Collaborate on functional strategy: set mid-term goals, strategic priorities, and ensure execution aligns with objectives and financial performance targets.
- Provide strategic oversight of regulatory function through managers/leaders.
- Partner with executive stakeholders to negotiate and influence critical regulatory matters.
- Develop and execute corporate regulatory policies.
- Lead interactions with global health authorities (FDA, EMA, and others) and shape regulatory pathway decisions.
- Ensure regulatory compliance throughout the product lifecycle.
- Oversee preparation and submission of INDs, CTAs, NDAs, BLAs, and MAAs.
- Direct regulatory strategy for expedited programs and rare disease designations (Fast Track, Orphan Drug, Breakthrough Therapy, RMAT).
- Lead inspections/audits and ensure corrective actions are implemented.
- Mentor regulatory leaders; develop and mentor the regulatory affairs team.
- Monitor global regulatory trends and provide guidance to senior leadership.
- Collaborate cross-functionally for product development and launch.
Education And Skills Requirements:
- Bachelor’s degree in life sciences or related field (Master’s preferred).
- 18+ years progressive regulatory affairs experience; 10+ years in management/leadership.
- Deep regulatory strategy expertise for clinical-stage biotech; strong CTD format/content experience.
- Demonstrated knowledge of FDA, EMA, and international regulations (clinical, nonclinical, CMC).
- Experience leading health authority meetings and influencing regulatory decisions.
- Strong communication skills (regulatory writing, cross-functional collaboration).
- Ability to apply strategic thinking and foster innovation.
- Models values of purpose, commitment, vision, resolve.
Pay Range:
- $250,000 - $310,000 USD
Executive Director, Regulatory Affairs. Based in Waltham, MA. Leads long-term regulatory strategy, oversees compliance across the product lifecycle, and drives regulatory functional direction and organizational alignment.
Primary Responsibilities:
- Shape and lead comprehensive global regulatory strategy for a Dyne program.
- Collaborate on functional strategy: set mid-term goals, strategic priorities, and ensure execution aligns with objectives and financial performance targets.
- Provide strategic oversight of regulatory function through managers/leaders.
- Partner with executive stakeholders to negotiate and influence critical regulatory matters.
- Develop and execute corporate regulatory policies.
- Lead interactions with global health authorities (FDA, EMA, and others) and shape regulatory pathway decisions.
- Ensure regulatory compliance throughout the product lifecycle.
- Oversee preparation and submission of INDs, CTAs, NDAs, BLAs, and MAAs.
- Direct regulatory strategy for expedited programs and rare disease designations (Fast Track, Orphan Drug, Breakthrough Therapy, RMAT).
- Lead inspections/audits and ensure corrective actions are implemented.
- Mentor regulatory leaders; develop and mentor the regulatory affairs team.
- Monitor global regulatory trends and provide guidance to senior leadership.
- Collaborate cross-functionally for product development and launch.
Education And Skills Requirements:
- Bachelor’s degree in life sciences or related field (Master’s preferred).
- 18+ years progressive regulatory affairs experience; 10+ years in management/leadership.
- Deep regulatory strategy expertise for clinical-stage biotech; strong CTD format/content experience.
- Demonstrated knowledge of FDA, EMA, and international regulations (clinical, nonclinical, CMC).
- Experience leading health authority meetings and influencing regulatory decisions.
- Strong communication skills (regulatory writing, cross-functional collaboration).
- Ability to apply strategic thinking and foster innovation.
- Models values of purpose, commitment, vision, resolve.
Pay Range:
- $250,000 - $310,000 USD