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.
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 providing guidance to executive leadership. Additionally, the role involves overseeing clinical trial planning, execution, and ensuring compliance with GCP, ICH guidelines, and other global regulatory requirements. The Vice President will also lead medical affairs functions, including building strategic 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, as well as expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements. The role demands a leader with the ability to drive organizational growth, lead cross-functional teams, and operate effectively in a fast-paced, highly regulated environment.
Functions
- Operations
- Medical Care/Hospital Administration
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