Senior Vice President, Global Regulatory Affairs
Confidential, Boston, MA, United States
Senior Vice President, Global Regulatory Affairs
About the Company
Esteemed biotechnology company developing innovative oncology therapeutics
Industry Biotechnology
Type Privately Held
About the Role
The Company is in search of a Senior Vice President, Global Regulatory Affairs to spearhead the regulatory vision for its innovative oncology pipeline. The successful candidate will be the senior-most regulatory leader, tasked with developing and driving global regulatory strategy from early development to post-marketing planning. This pivotal role involves leading regulatory interactions with global health authorities, guiding registration pathways for therapeutics and associated enabling technologies, and building the necessary infrastructure for commercialization. The ideal candidate is a hands-on regulatory innovator with a strong background in global oncology regulatory strategies, particularly in the context of accelerated and expedited pathways.
Key responsibilities for the SVP, Global Regulatory Affairs include leading regulatory planning for programs pursuing accelerated approval, serving as the primary regulatory voice to executive and Board-level stakeholders, and overseeing all regulatory documentation and submissions for late-stage development. The role also requires the candidate to provide strategic direction for regulatory pathways involving patient-selection tools and to collaborate closely with cross-functional teams, including translational sciences, clinical development, and external partners. The candidate should have a proven track record in leading or co-leading regulatory strategy for programs involving novel biomarkers and diagnostics, and be adept at building, scaling, and mentoring high-performing global regulatory teams. A minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a focus on global oncology, is essential, as is a strong background in communication, scientific fluency, and the ability to translate complex data into regulatory strategy.
Travel Percent Less than 10%
Functions
Operations
About the Company
Esteemed biotechnology company developing innovative oncology therapeutics
Industry Biotechnology
Type Privately Held
About the Role
The Company is in search of a Senior Vice President, Global Regulatory Affairs to spearhead the regulatory vision for its innovative oncology pipeline. The successful candidate will be the senior-most regulatory leader, tasked with developing and driving global regulatory strategy from early development to post-marketing planning. This pivotal role involves leading regulatory interactions with global health authorities, guiding registration pathways for therapeutics and associated enabling technologies, and building the necessary infrastructure for commercialization. The ideal candidate is a hands-on regulatory innovator with a strong background in global oncology regulatory strategies, particularly in the context of accelerated and expedited pathways.
Key responsibilities for the SVP, Global Regulatory Affairs include leading regulatory planning for programs pursuing accelerated approval, serving as the primary regulatory voice to executive and Board-level stakeholders, and overseeing all regulatory documentation and submissions for late-stage development. The role also requires the candidate to provide strategic direction for regulatory pathways involving patient-selection tools and to collaborate closely with cross-functional teams, including translational sciences, clinical development, and external partners. The candidate should have a proven track record in leading or co-leading regulatory strategy for programs involving novel biomarkers and diagnostics, and be adept at building, scaling, and mentoring high-performing global regulatory teams. A minimum of 15 years of regulatory experience in the biopharmaceutical industry, with a focus on global oncology, is essential, as is a strong background in communication, scientific fluency, and the ability to translate complex data into regulatory strategy.
Travel Percent Less than 10%
Functions
Operations