Head of Global Regulatory Strategy
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About the Role
Greater Santa Ana, CA Area (On-site)
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 strong background in regulatory affairs, particularly within the biotechnology, pharmaceuticals, or medical devices sectors, and a minimum of 10 years of direct experience in injectable aesthetics or closely related therapeutic areas. The Head of Global Regulatory Strategy will also be tasked with building and leading a large international 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 being preferred. A minimum of 15 years of regulatory affairs experience is required, with a significant background in FDA interactions and a strong understanding of CDRH requirements for medical devices. The ideal candidate will have a proven track record in developing and leading global regulatory strategy, as well as experience in managing large global teams in a matrixed environment. Exceptional communication, executive presence, and stakeholder management skills are essential. While not mandatory, direct experience with neurotoxins, the aesthetic medicine industry, and combination product regulatory pathways is highly valued. The role demands a professional who can assess regulatory risks, develop mitigation strategies, and support the company's business objectives and program timelines.
Functions:
- Strategy
- Operations
Compensation
USD $250,000-$350,000 (salary) per year
About the Company
Global biopharmaceutical company developing injectable aesthetics products and neurotoxin therapies
Industry
Biotechnology
Type
Privately Held
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