JobMesh

Regulatory Strategy Senior Director

Vertex · Boston, Massachusetts, US

Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the a...

Job description

Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered Vertex medicines, and/or (3) for the support of Vertex marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. This is a Boston based, hybrid position requiring 3 days/week onsite. Key Duties & Responsibilities: - Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application st...