Regulatory Affairs Executive Director - Global Strategy

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

Job summary

Dyne Therapeutics is seeking an Executive Director, Regulatory Affairs to shape long-term regulatory strategy and drive cross-functional execution across global programs. You will lead regulatory policy, interact with health authorities, and mentor a high-performing team in a fast-paced biotech environment.

Based in Waltham, MA, you will oversee IND/CTA filings, designations, and performance metrics, ensuring regulatory excellence and alignment with patient outcomes and corporate goals.

Qualifications

• Bachelor's degree in life sciences required; Master's preferred.
• 18+ years of progressive regulatory affairs experience with at least 10 years in management/leadership.
• Deep expertise in regulatory strategy for clinical-stage biotech companies; CTD experience essential.
• Strong knowledge of FDA/EMA and international regulatory requirements for clinical, nonclinical, and CMC.
• Proven ability to lead health authority interactions and influence enterprise regulatory decisions.
• Outstanding regulatory writing, communications, and cross-functional collaboration skills.

Responsibilities

• Lead global regulatory strategy for Dyne programs and set long-term objectives.
• Develop mid-term goals and ensure regulatory priorities align with financial targets.
• Oversee regulatory function through managers, promoting emotionally intelligent leadership.
• Partner with executives to influence critical regulatory matters and regulatory pathway decisions.
• Craft corporate regulatory policies that align with patient outcomes and company direction.
• Lead interactions with FDA, EMA, and other authorities and represent the company at strategic meetings.
• Ensure lifecycle regulatory compliance across programs and submissions (INDs/CTAs/NDAs/BLAs/MAAs).
• Direct strategy for expedited programs and designations (Fast Track, Orphan, Breakthrough).
• Mentor regulatory team and build capability for long-term growth and high performance.
• Collaborate cross-functionally for successful product development and launches.

Skills

Regulatory strategy

FDA/EMA/regulatory leadership

Regulatory submissions

Cross-functional leadership

Strategic thinking

Regulatory writing/communications

Education

Bachelor's degree in life sciences

Master's degree preferred

Job description

Dyne Therapeutics is seeking an Executive Director, Regulatory Affairs to shape long-term regulatory strategy and drive cross-functional execution across global programs. You will lead regulatory policy, interact with health authorities, and mentor a high-performing team in a fast-paced biotech environment.

Based in Waltham, MA, you will oversee IND/CTA filings, designations, and performance metrics, ensuring regulatory excellence and alignment with patient outcomes and corporate goals.