Head of Global Regulatory Strategy
Confidential
Head of Global Regulatory Strategy
About the Company
Global biopharmaceutical company leading injectable aesthetics and neurotoxin programs.
Industry
Biotechnology
Type
Privately Held
About the Role
The Company is in search of a Head of Global Regulatory Strategy to provide strategic leadership for a high-profile portfolio of injectable aesthetic products, with a primary focus on neurotoxin programs and lifecycle strategy. The successful candidate will be responsible for developing and executing global regulatory strategies, leading interactions with FDA and international health authorities, and providing oversight for medical device programs. This role requires a seasoned professional with a minimum of 15 years' regulatory affairs experience, including at least 10 years in injectable aesthetics or closely related therapeutic areas, and a strong background in both biologic and medical device products. The Head of Global Regulatory Strategy will also be tasked with building and leading a high-performing global regulatory organization, mentoring future leaders, and influencing senior stakeholders across various functions. Applicants for the Head of Global Regulatory Strategy position at the company should hold a Bachelor's degree, with an advanced scientific, medical, pharmacy, or regulatory degree preferred. The role demands a candidate with a proven track record in developing and leading global regulatory strategy, significant FDA experience, and a strong understanding of CDRH requirements for medical devices. Experience in the aesthetic medicine industry, particularly with neurotoxins, and a background in combination products are highly valued. The ideal candidate will have exceptional executive presence, communication skills, and the ability to manage and influence a large, international team in a matrixed environment. Responsibilities also include assessing regulatory risks, developing mitigation strategies, and supporting the evaluation of external innovation and business development opportunities.
Functions
- Strategy
- Operations
Vacancy posted 5 days ago
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