Vice President, Regulatory Science Communications
Biotechnology
The Company is seeking a Vice President for Regulatory Science Communications to lead a diverse and growing team in the preparation and submission of critical regulatory documents. The successful candidate will be responsible for the functional areas of scientific and regulatory writing, editing, and document quality control, ensuring the timely and high-quality delivery of documents across all stages of development. This role involves providing expert leadership, building and maintaining an effective team, and overseeing the development of standards, procedures, and processes for regulatory document development. The Vice President will also be involved in strategic planning, resource management, and continuous improvement initiatives.
Key requirements for the role include a BS/BA, MS/MA, or PhD in a related discipline, with a minimum of 17 years of experience, and a preference for a PhD. The ideal candidate will have a strong background in regulatory requirements, industry practices, and experience in the preparation of complex documents for regulatory submissions, particularly IND, NDA/BLA/MAA. Certification in a relevant field is preferred, as is in-depth experience with electronic systems for submissions. The role demands a strategic and proactive approach, the ability to engage and influence stakeholders, and a proven track record of leadership and management in a regulatory or scientific environment.
Travel Percent
General Management
Operations
Confidential