Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
Confidential
Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs
About the Company
An innovative, patient-focused biotechnology company advancing cancer therapies.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of a Vice President for Regulatory Affairs, Clinical Operations, and Medical Affairs. This executive leadership role is pivotal in driving the strategic development and execution of global regulatory strategies for product development, clinical studies, manufacturing changes, and commercialization. The successful candidate will be responsible for leading the preparation and maintenance of various regulatory submissions, serving as the primary liaison with regulatory agencies, and ensuring compliance with global regulatory requirements. Additionally, the role involves providing strategic oversight of clinical trial planning, execution, and CRO/vendor management, as well as leading medical affairs functions, including building partnerships with Key Opinion Leaders, guiding scientific communications, and supporting evidence generation and post-marketing activities. Applicants for the Vice President position at the company should hold an advanced degree, with a medical degree being preferred, and have a minimum of 15 years' progressive leadership experience in the biotechnology, pharmaceuticals, or related fields. A minimum of 10 years in regulatory affairs leadership is required, along with significant experience in overseeing clinical operations and medical affairs. The ideal candidate will have a proven track record in regulatory submissions, agency interactions, and supporting products through commercialization, and possess expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements. The role demands a leader with the ability to manage, coach, and develop functional teams, oversee departmental budgets, and foster a culture of compliance, innovation, and results in a fast-paced, highly regulated environment.
Functions
- Operations
- Medical Care/Hospital Administration
Vacancy posted 2 days ago
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