Global Head of Regulatory Strategy Aesthetics Neurotoxins

EPM Scientific; Irvine (CA); On-site; USD 250,000 - 420,000; Full time

Job summary

EPM Scientific is seeking a Head of Global Regulatory Strategy to lead regulatory strategy for an injectable aesthetics portfolio, including neurotoxins, biologics, and device components. The role oversees an international regulatory organization across North America and Europe, partnering with executives to drive regulatory success across development and post-market activities.

The ideal candidate has 15+ years in regulatory affairs within biotech/pharma or medical devices, with strong

Qualifications

• Bachelor's degree required; advanced scientific, medical, pharmacy, or regulatory degree preferred.
• 15+ years of regulatory affairs experience within biotech, pharma, medical devices, or combination products.
• Minimum 10 years of direct experience supporting injectable aesthetics, neurotoxins, or related areas.
• Demonstrated experience developing and leading global regulatory strategies and interacting with CDRH/CBER.

Responsibilities

• Develop and execute global regulatory strategies for injectable aesthetic products, focusing on neurotoxins and related biologics assets.
• Lead regulatory interactions with FDA, international authorities, and notified bodies to support development, approvals, and lifecycle management.
• Provide strategic oversight for medical device programs and combination-product initiatives requiring CDRH engagement.
• Drive regulatory strategy for major development and post-marketing initiatives and FDA negotiations.
• Serve as senior regulatory representative on cross-functional governance and leadership committees.
• Offer guidance on evolving regulatory requirements, policy developments, and emerging scientific considerations in aesthetics.
• Assess regulatory risks and develop mitigation strategies to support timelines and business objectives.
• Support evaluation of external opportunities, BD activities, and portfolio expansion; build a high-performing global regulatory organization.

Skills

Regulatory strategy

Regulatory leadership

FDA interactions

Cross-functional leadership

Executive presence

Regulatory policy

Global regulatory affairs

Life-cycle management

Medical device regulations

Biologics experience

Education

Bachelor's degree

Advanced/regulatory degree preferred

Job description

EPM Scientific is seeking a Head of Global Regulatory Strategy to lead regulatory strategy for an injectable aesthetics portfolio, including neurotoxins, biologics, and device components. The role oversees an international regulatory organization across North America and Europe, partnering with executives to drive regulatory success across development and post-market activities.

The ideal candidate has 15+ years in regulatory affairs within biotech/pharma or medical devices, with strong