Executive Director
Confidential
Executive Director, Global Regulatory Strategy
About the Company
Global biopharmaceutical company developing injectable aesthetics, biologic, and medical device products.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of an Executive Director, Global Regulatory Strategy to spearhead the regulatory approach for a prominent portfolio of injectable aesthetics products, with a focus on neurotoxin programs. The successful candidate will be responsible for developing and executing global regulatory strategies, leading interactions with health authorities, and providing strategic oversight for both biologic and medical device products. This role demands a leader with a strong background in regulatory affairs, particularly within the biotechnology, pharmaceuticals, or medical devices sectors, and a minimum of 10 years' direct experience in injectable aesthetics or related therapeutic areas. The Executive Director will also be tasked with building and leading a high-performing global regulatory organization, influencing senior leadership, and ensuring compliance with evolving regulatory requirements. Applicants for the Executive Director position at the company should hold a Bachelor's degree, with an advanced scientific, medical, pharmacy, or regulatory degree being preferred. A proven track record of at least 15 years in regulatory affairs, including significant experience with the FDA and a strong understanding of CDRH requirements, is essential. The role requires exceptional leadership, communication, and stakeholder management skills, as well as the ability to mentor and develop a large team of regulatory professionals. Experience in the aesthetic medicine industry, particularly with neurotoxins, and a background in combination products with both drug and device regulatory pathways, are highly valued. The ideal candidate will have a deep knowledge of regulatory policy developments in the aesthetics, biologics, and medical device sectors, and the ability to assess and mitigate regulatory risks to support business objectives.
Functions
- Strategy
- Operations
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