Confidential
Vice President, Global Regulatory Affairs
Confidential, San Jose, California, United States, 95101
Vice President, Global Regulatory Affairs
About the Company
Forward-thinking biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Vice President, Head of Global Regulatory Affairs to join their team. The successful candidate will be responsible for providing strategic and operational leadership in all regulatory functions, ensuring compliance with global health authority regulations, and driving the company's business objectives. This role involves leading the planning and execution of critical regulatory milestones, including the preparation, review, and submission of various key filings. The ideal candidate will be a forward-thinking regulatory leader with a deep understanding of the evolving regulatory landscape, particularly in the context of innovative therapies. They will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.
Key responsibilities for the Vice President, Head of Global Regulatory Affairs include creating and executing global regulatory strategies, maintaining regulatory knowledge of US, EU, and global regulations, and managing all activities related to interactions with health authorities. The role requires a candidate with a strong background in regulatory affairs, including hands-on experience in leading clinical trials and a proven track record of successful interactions with global regulatory agencies. Experience in oncology and/or hematology is preferred, as is a background in bio-pharmaceuticals. The candidate should possess excellent communication skills, strong leadership abilities, and the capacity to work in an agile, small company environment. A degree in MD, Ph.D., or Pharm D. is preferred, along with at least 15 years of experience in the field.
Travel Percent Less than 10%
Functions
General Management Operations Strategy
About the Company
Forward-thinking biotech company
Industry Biotechnology
Type Privately Held
About the Role
The Company is seeking a Vice President, Head of Global Regulatory Affairs to join their team. The successful candidate will be responsible for providing strategic and operational leadership in all regulatory functions, ensuring compliance with global health authority regulations, and driving the company's business objectives. This role involves leading the planning and execution of critical regulatory milestones, including the preparation, review, and submission of various key filings. The ideal candidate will be a forward-thinking regulatory leader with a deep understanding of the evolving regulatory landscape, particularly in the context of innovative therapies. They will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.
Key responsibilities for the Vice President, Head of Global Regulatory Affairs include creating and executing global regulatory strategies, maintaining regulatory knowledge of US, EU, and global regulations, and managing all activities related to interactions with health authorities. The role requires a candidate with a strong background in regulatory affairs, including hands-on experience in leading clinical trials and a proven track record of successful interactions with global regulatory agencies. Experience in oncology and/or hematology is preferred, as is a background in bio-pharmaceuticals. The candidate should possess excellent communication skills, strong leadership abilities, and the capacity to work in an agile, small company environment. A degree in MD, Ph.D., or Pharm D. is preferred, along with at least 15 years of experience in the field.
Travel Percent Less than 10%
Functions
General Management Operations Strategy