Executive Director & Vice President, Head of Regulatory Affairs
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1991
Employees
201-500
Categories
Business Classifications
About the Role
The Company is in search of an Executive Director/Vice President, Head of Regulatory Affairs to join their dynamic team. The successful candidate will be a key leader in the global strategy development and execution of regulatory affairs objectives. This pivotal role involves overseeing the design and execution of clinical trials, managing all regulatory submissions, and ensuring the company's regulatory goals align with industry standards. The ideal candidate will have a scientific background, with a Ph.D. or PharmD. preferred, and a proven track record in the pharmaceutical or biotech industry. Experience in FDA regulations, ICH guidelines, and a strong background in drug development processes are essential. Responsibilities for this position at the company include collaborating with cross-functional teams, providing regulatory expertise for product opportunities, and leading the regulatory affairs team. The role demands a strategic thinker with the ability to anticipate global regulatory changes and develop proactive strategies. The candidate should be results-driven, team-oriented, and have excellent communication skills to interact with both internal and external stakeholders. Experience in inhalation products and biologics, as well as post-approval change management and product life cycle management, is highly valued. The individual must be prepared to work in a fast-paced environment, exhibit a passion for patient care, and be willing to travel as needed.
Hiring Manager Title
Chief Medical Officer
Travel Percent
15%
Functions
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