Vice President, Regulatory Affairs
About the Company
Innovative provider of surgical solutions for peripheral nerve injuries
Industry
Biotechnology
Type
Public Company
Founded
2002
Employees
201-500
Categories
Specialties
About the Role
The Company is seeking a Vice President of Regulatory Affairs to join their Executive Team. The successful candidate will be responsible for the development and execution of domestic and international regulatory strategies in alignment with the company's mission to restore health and improve the quality of life. This includes leading regulatory activities for new product and therapy development, market approval, and ongoing product registrations. The VP, Regulatory Affairs will also be involved in shaping regulatory policy with external groups and must have a proven track record of managing regulatory interactions, including Biologics License Applications and other relevant submissions. The role requires a strategic leader with the ability to cultivate relationships with regulatory agencies and industry groups, as well as a strong background in regulatory affairs within the regenerative medicine, medical device, or pharmaceutical sectors. Candidates for the VP, Regulatory Affairs position at the company should have a Bachelor's degree (Master's or Doctorate preferred) and at least 15 years' of experience in a related field, with a focus on biologics. A minimum of 5 years' in a leadership role with direct reports is essential. The ideal candidate will have a deep understanding of regulatory processes and a history of successful interactions with the FDA and other international regulatory bodies. Key responsibilities include acting as the authorized regulatory representative, managing regulatory strategy, and overseeing a team to ensure compliance with all relevant regulations. The role demands excellent communication, analytical, and organizational skills, as well as the ability to build and maintain strong, collaborative relationships both internally and externally.
Hiring Manager Title
Chief Executive Officer
Travel Percent
Less than 10%
Functions
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