Head of Global Regulatory Strategy

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

A global biopharmaceutical company is seeking Head of Global Regulatory Strategy to lead regulatory strategy for a high-profile injectable aesthetics portfolio. This individual will provide strategic leadership across both biologic and medical device products, with primary responsibility for neurotoxin programs and lifecycle strategy.

This Vice President will serve as the regulatory leader for a growing global business and oversee a large international regulatory organization spanning North America and Europe. This position will partner closely with executive leadership, development, commercial, medical affairs, and external health authorities to drive regulatory success across both development and marketed products.

Key Responsibilities

• Develop and execute global regulatory strategies for injectable aesthetic products with an emphasis on neurotoxins and related biologic assets.
• Lead regulatory interactions with FDA, international health authorities, and notified bodies to support development programs, approvals, label expansions, and lifecycle management activities.
• Provide strategic oversight for medical device programs and combination-product initiatives requiring CDRH engagement.
• Drive regulatory strategy for significant development and post-marketing initiatives, including indication expansions and major FDA interactions.
• Serve as the senior regulatory representative on cross-functional governance and leadership committees.
• Provide expert guidance regarding evolving regulatory requirements, policy developments, and emerging scientific considerations impacting the aesthetics landscape.
• Assess regulatory risks and develop mitigation strategies to support business objectives and program timelines.
• Support evaluation of external innovation opportunities, business development initiatives, and portfolio expansion programs.
• Build and lead a high-performing global regulatory organization across the U.S. and Europe.

Leadership Responsibilities

• Lead a global team of approximately 25+ regulatory professionals across North America and Europe.
• Mentor and develop future regulatory leaders while fostering a collaborative and accountable culture.
• Manage departmental priorities, resource allocation, vendor relationships, and budget planning.
• Influence senior leadership and key stakeholders across R&D, commercial, medical, quality, and operations functions.

Qualifications

• Bachelor's degree required; advanced scientific, medical, pharmacy, or regulatory degree preferred.
• 15+ years of regulatory affairs experience within biotechnology, pharmaceuticals, medical devices, or combination products.
• Minimum 10 years of direct experience supporting injectable aesthetics, neurotoxins, or closely related therapeutic areas.
• Demonstrated experience developing and leading global regulatory strategy, interacting with both CDRH and CBER
• Significant FDA experience, including direct interactions supporting major submissions and agency negotiations.
• Strong understanding of CDRH requirements and regulatory pathways for medical devices.
• Experience leading large global teams in a matrixed environment.
• Knowledge of regulatory policy developments impacting aesthetics, biologics, and medical devices strongly preferred.
• Exceptional executive presence, communication skills, and stakeholder management capabilities.

Preferred Background

• Direct neurotoxin experience highly preferred.
• Experience within the aesthetic medicine industry strongly preferred.
• Combination product experience including both drug and device regulatory pathways preferred.
• Regulatory policy experience supporting FDA engagement and emerging regulatory frameworks is a plus.