Global Regulatory Strategy Executive Director

Regulatory Jobs; Waltham (MA); On-site; USD 294,000 - 318,000; Full time

Job summary

Dyne Therapeutics seeks an Executive Director of Regulatory Affairs to shape long-term regulatory strategy and provide strategic direction across regulatory operations in support of patient-centered programs.

The role requires deep expertise with FDA/EMA regulations, CTD filings, and a proven track record in leading regulatory teams through complex interactions and filings. Based in Waltham, MA, this position emphasizes leadership, collaboration, and delivering timely regulatory outcomes.

Qualifications

• Bachelor's degree in life sciences or related field required, Master's preferred.
• 18+ years in regulatory affairs with at least 10 years in management.
• Deep expertise in regulatory strategy for clinical-stage biotech, CTD format and filings.
• Strong knowledge of FDA/EMA and international regulations.

Responsibilities

• Shape and lead global regulatory strategy for Dyne programs.
• Collaborate to set mid-term goals and ensure execution with financial targets.
• Provide strategic oversight of regulatory functions through leaders.
• Negotiate with health authorities and influence enterprise decisions.
• Develop corporate regulatory policies aligning with patient outcomes.
• Lead interactions with FDA, EMA and other agencies.
• Oversee major filings (INDs, CTAs, NDAs, BLAs, MAAs) and lifecycle compliance.
• Mentor regulatory professionals and build organizational capability.
• Embed Dyne values and emotional intelligence into regulatory operations.

Skills

Regulatory strategy

Leadership

Regulatory writing

Cross-functional collaboration

FDA knowledge

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

Dyne Therapeutics seeks an Executive Director of Regulatory Affairs to shape long-term regulatory strategy and provide strategic direction across regulatory operations in support of patient-centered programs.

The role requires deep expertise with FDA/EMA regulations, CTD filings, and a proven track record in leading regulatory teams through complex interactions and filings. Based in Waltham, MA, this position emphasizes leadership, collaboration, and delivering timely regulatory outcomes.