Executive Director/Vice President, Regulatory Affairs
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1994
Employees
51-200
Categories
About the Role
The Company is seeking an Executive Director/Vice President of Regulatory Affairs to join their team. The successful candidate will be tasked with developing and implementing innovative global regulatory strategies that align with the company's business objectives. This role involves leading a strategic approach to global regulatory activities, representing the company with regulatory authorities, and providing essential regulatory support across various departments and projects. The ideal candidate will have a strong background in regulatory affairs, with a focus on clinical, non-clinical, and CMC regulatory strategies, and a proven track record of successful interactions with major health authorities. Key responsibilities for this position include directing the company's regulatory strategies, providing guidance throughout the product development process, and overseeing the preparation and submission of regulatory documents. The role also requires the building and maintenance of relationships with regulatory agencies, as well as the supervision of a regulatory team to ensure the adequacy of project support. The candidate should have extensive experience in regulatory affairs, particularly in the context of rare and ultra-rare diseases, and be well-versed in GCPs, GLPs, and eCTD submission processes. Strong leadership, communication, and organizational skills are essential, as is the ability to work effectively in a small biotech company environment.
Hiring Manager Title
CMO
Travel Percent
Less than 10%
Functions
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