Executive Director of Regulatory Affairs
About the Company
Leading provider of advanced pharmaceutical & biotechnology solutions
Industry
Pharmaceuticals
Type
Subsidiary of a Public Company
Founded
1995
Employees
1001-5000
Categories
Specialties
Business Classifications
About the Role
The Company is seeking an Executive Director of Regulatory Affairs with a focus on neurology and oncology. The successful candidate will be responsible for providing global regulatory leadership in the development, registration, and life-cycle management of products. This includes the development of regulatory strategies, directing the submission of various regulatory applications, and providing strategic product direction to project teams. The role also involves oversight of regulatory teams, ensuring the completion of regulatory goals, and maintaining compliance with regulatory requirements. The ideal candidate will have a Bachelor's degree in a scientific discipline, with a Master's or advanced degree preferred, and at least 12 years of industry experience, including a minimum of 10 years in direct regulatory affairs within the biotech or biopharmaceutical industry. Key responsibilities for the Executive Director of Regulatory Affairs at the company include serving as the lead regulatory representative on project teams, providing senior staff advice on regulatory issues, and actively participating in health authority inspections. The role requires a candidate with a proven track record of successful interactions with global regulatory agencies, experience in managing the preparation of marketing applications in CTD format, and strong strategic and operational skills. The candidate should also possess excellent communication, interpersonal, and leadership skills, and the ability to work effectively in a matrix organization. A sense of urgency and perseverance to achieve results is essential, as is the ability to lead and manage teams across different regions.
Travel Percent
Less than 10%
Functions
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