Head of Global Regulatory Strategy

Head of Global Regulatory Strategy

About the Company

Global biopharmaceutical company developing injectable aesthetics and neurotoxin products.

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 aesthetics 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, 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 stakeholders at all levels. Responsibilities also include assessing regulatory risks, developing mitigation strategies, and supporting the evaluation of external innovation opportunities and business development initiatives.

Functions

• Strategy
• Operations