Global Regulatory Strategy Director

Dyne Tx; Waltham (MA); On-site; USD 250,000 - 310,000; Full time

Job summary

Dyne Tx is seeking an Executive Director of Regulatory Affairs to lead strategic program direction and compliance with regulatory standards. You will shape regulatory strategies by collaborating with key stakeholders and overseeing major regulatory filings.

The ideal candidate will have over 18 years of experience in regulatory affairs, with a strong background in clinical-stage biotechnology and leadership roles. This position offers a competitive salary range of $250,000 to $310,000.

Qualifications

• 18+ years of progressive experience in regulatory affairs with at least 10 years in management roles.
• Deep expertise in regulatory strategy for clinical-stage biotechnology companies.
• Demonstrated knowledge of FDA, EMA, and international regulations.

Responsibilities

• Shape and lead comprehensive global regulatory strategy.
• Ensure compliance with regulatory requirements throughout the product lifecycle.
• Lead interactions with global health authorities and manage regulatory filings.

Skills

Regulatory strategy expertise

Leadership skills

Communication skills

Strategic thinking

Team mentoring

Education

Bachelor’s degree in life sciences

Master’s degree preferred

Job description

Dyne Tx is seeking an Executive Director of Regulatory Affairs to lead strategic program direction and compliance with regulatory standards. You will shape regulatory strategies by collaborating with key stakeholders and overseeing major regulatory filings.

The ideal candidate will have over 18 years of experience in regulatory affairs, with a strong background in clinical-stage biotechnology and leadership roles. This position offers a competitive salary range of $250,000 to $310,000.