Global Head of Injectable Aesthetics Regulatory Strategy

Galderma

Global regulatory executive leading injectable aesthetics approvals and lifecycle strategy at Galderma, a global dermatology company. Managing FDA interactions, submissions, compliance, recalls, and regulatory staff.

Posted 8/4/2026full-timeMiami • 🇺🇸 United StatesLead💰 $260,000 - $365,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory Affairs for Injectable Aesthetics, including the development and execution of regulatory strategies, compliance with product regulations, and management of regulatory submissions. Proven ability to lead teams, influence cross-functional collaboration, and maintain relationships with regulatory agencies.

Highest-signal resume keywords

Regulatory Affairs LeadershipRegulatory Strategy DevelopmentRegulatory Submissions ManagementClinical Data ReviewTeam Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyRegulatory SubmissionsClinical Data ReviewDrug DevelopmentRegulatory ComplianceAdverse Drug Reaction ReportingRegulatory Submission PathwaysClinical StatisticsProduct Launch StrategyRegulatory Agency Relationships

Soft Skills

Interpersonal SkillsOrganizational SkillsCommunication SkillsEmployee ManagementHigh Integrity

Industry Keywords

Injectable AestheticsNeurotoxinsFillersMedical DevicesPharmaceutical Regulatory AffairsFDA RegulationsProduct RegulationsCross-Functional CollaborationMarket ApprovalsProduct Distribution

About the role

Key responsibilities & impact

Lead the Global Regulatory Affairs Injectable Aesthetics team
Develop and execute regulatory strategies for injectable aesthetic products, including neurotoxins, fillers, and other medical devices
Ensure compliance with pre- and post-market product regulations and standards
Drive timely approvals and successful launches of new products and changes to marketed products
Oversee regulatory submissions supporting clinical research, new marketing applications, Variations, Supplements, and Amendments
Serve as global subject matter expert for local and global partners
Advise on regulatory requirements for acquisitions, integrations, and new product development
Represent Regulatory Affairs on the Injectable Aesthetics Steering Committee and senior cross-functional committees
Lead field action and recall assessment processes and communications with regulatory authorities
Create and maintain procedures and tools to improve functional efficiency and cross-functional communication
Partner with Global R&D on Nonclinical and Clinical strategies and protocols
Provide regulatory support to Medical, Legal, Commercial, and other functions
Track regulatory status of products and recommend areas requiring attention
Resolve regulatory concerns affecting product distribution or promotional activities
Lead and develop staff through feedback, coaching, and career support
Manage the department budget and operating costs

Requirements

What you’ll need

Bachelor's degree from a four-year university required; advanced degree preferred
Minimum of 20 years of experience in Pharmaceutical Regulatory Affairs required
Minimum of 15 years of experience reviewing clinical and nonclinical data supporting advertising and promotion of pharmaceutical products required
Minimum of 10 years of experience managing staff required
Extensive knowledge of laws and regulations for developing, labeling, and promoting prescription drugs and medical devices
Thorough working knowledge of drug development, submission-to-approval processes, and adverse drug reaction reporting and analysis
Firm understanding of regulatory submission pathways, review times, and fees for drugs and devices
Knowledge of clinical statistics and evaluation of clinical and non-clinical data
Experience managing and collaborating in complex organizational structures and influencing across organizations
Ability to develop and cultivate relationships with FDA and other regulatory agencies
Proven experience guiding complex regulatory strategies and implementing them across organizations
High integrity and professionalism with ability to establish internal and external credibility
High sense of urgency and commitment to execution
Ability to handle confidential information appropriately and comply with policies and regulations
Excellent verbal and written communication, interpersonal, organizational, and employee management skills
Ability to perform standard office activities, including extended computer use and virtual and in-person meetings
Occasional travel may be required
Must be eligible to work in the United States; work authorization sponsorship is not offered

Benefits

Comp & perks

Annual short-term incentive program
Annual long-term incentive program
Medical coverage
Dental coverage
Vision coverage
401(k) plan with employer match
Paid time off
Opportunities for growth, development, and collaboration
Inclusive and innovative environment