Executive Director, Global Regulatory Strategy — C&GT

Vertex Inc.; Washington (District of Columbia); Híbrido; USD 268.000 - 402.000; Jornada completa

Descripción de la vacante

Vertex is seeking an Executive Director, Regulatory Strategy for the Type 1 Diabetes portfolio. You will lead global regulatory strategy development, mentor a team of regulatory professionals, and partner with clinical, development, and commercial groups to align programs with corporate objectives.

You will drive interactions with health authorities, shape regulatory paths for development from FIH through post-marketing, and oversee timely submissions while advancing innovation and compliance

Formación

• Requires extensive regulatory affairs experience in pharma/biotech.
• Strong leadership and cross-functional collaboration.
• Experience with global regulatory submissions and health authorities.

Responsabilidades

• Leads development of regulatory strategy for multiple T1D projects from FIH to post-approval.
• Ensures regulatory programs align with corporate objectives and health authority negotiations.
• Guides cross-functional teams with regulatory input and strategy.
• Contributes to submission documents and health authority communications.
• Mentors staff and manages resource planning and timelines.
• Represents regulatory leadership in industry meetings and collaborations.

Conocimientos

Regulatory strategy leadership

Global/regional regulatory

Drug development expertise

Strategic leadership

Health Authority interactions

Educación

Bachelor’s degree in Biology or Chemistry

Descripción del empleo

Vertex is seeking an Executive Director, Regulatory Strategy for the Type 1 Diabetes portfolio. You will lead global regulatory strategy development, mentor a team of regulatory professionals, and partner with clinical, development, and commercial groups to align programs with corporate objectives.

You will drive interactions with health authorities, shape regulatory paths for development from FIH through post-marketing, and oversee timely submissions while advancing innovation and compliance