Global Regulatory Strategy Lead — Injectable Aesthetics

Galderma; Orange (CA); On-site; USD 260,000 - 365,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with employer match

Paid time off

Job summary

Galderma in Orange County, CA is seeking a strategic leader to serve as VP, Global Regulatory Strategy for Injectable Aesthetics. You will direct regulatory strategies for neurotoxins, fillers, and medical devices, ensuring timely approvals and ongoing compliance across development and post-market activities.

You will mentor a global team, collaborate with R&D, Medical, Legal and Commercial, manage agency interactions, and oversee submissions, variations, and recalls.

Qualifications

• Bachelor's degree from a four-year university required; advanced degree preferred.
• Minimum 20 years of Pharmaceutical Regulatory Affairs experience.
• Minimum 10–15 years reviewing clinical and nonclinical data in support of the advertising and promotion of pharmaceutical products.
• Minimum 10 years of experience managing staff.
• Extensive knowledge of laws and regulations for drugs and medical devices.
• Thorough understanding of the drug development process and regulatory submission pathways.
• Experience guiding complex regulatory strategies across large organizations.
• Proven ability to engage with FDA and other regulatory agencies.

Responsibilities

• Lead development and execution of regulatory strategies for injectable aesthetics products to ensure timely approvals and successful launches and changes.
• Provide guidance to Global R&D for submissions supporting clinical research and marketing applications.
• Serve as global SME on regulatory requirements and cross-functional implications.
• Collaborate with Global R&D to develop Nonclinical and Clinical strategies.
• Oversee field action and recall processes and related regulatory communications.
• Ensure department budget and operating costs are managed according to plan.
• Represent Regulatory Affairs on the Injectable Aesthetics Steering Committee and other senior committees.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

FDA relationships

Communication skills

Education

Bachelor's degree

Job description

Galderma in Orange County, CA is seeking a strategic leader to serve as VP, Global Regulatory Strategy for Injectable Aesthetics. You will direct regulatory strategies for neurotoxins, fillers, and medical devices, ensuring timely approvals and ongoing compliance across development and post-market activities.

You will mentor a global team, collaborate with R&D, Medical, Legal and Commercial, manage agency interactions, and oversee submissions, variations, and recalls.