Jobs · Business Development · California

Global Head of Injectable Aesthetics Regulatory Strategy

Galderma · Orange County, CA · 2 wk ago
Business Development$260k–$365k/yrFull-time

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ—the skin—meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. We look for people who focus on getting results, embrace learning, and bring positive energy, combining initiative with teamwork and collaboration. Above all, we value passion for making a meaningful difference for consumers, patients, and healthcare professionals.

About the role

The Global Head of Injectable Aesthetics Regulatory Strategy leads and manages the Global Regulatory Affairs Injectable Aesthetics team, developing and executing successful regulatory strategies for all injectable aesthetic products, including neurotoxins, fillers, and other medical devices. This role provides strategic and technical guidance to ensure compliance with regulations for products in development and on the market, enabling timely approvals and business continuity. Responsibilities include creating and managing procedures and processes for pre- and post-market compliance, as well as overseeing regulatory agency interactions.

Responsibilities

  • Lead the development and execution of regulatory strategies to ensure timely approval and launch of new products and changes to marketed products, considering strategic opportunities, business needs, and lifecycle management.
  • Provide oversight and critical input to Global R&D colleagues for key submission types, including those supporting clinical research (INDs and IDEs) and new marketing applications, Variations, Supplements, and Amendments.
  • Serve as the Global subject matter expert, offering guidance to local and global partners while considering company-wide implications.
  • Support and advise the company on regulatory requirements for acquisition integration and new product development.
  • Drive innovation by proposing viable projects aligned with business needs and regulations that fit company strategy.
  • Represent the Regulatory Affairs function on the Injectable Aesthetics Steering Committee and other senior-level cross-functional committees.
  • Lead activities related to field action and recall assessment processes, including communications to regulatory authorities.
  • Collaborate with the regulatory team and other functions to create and maintain procedures and tools that ensure functional efficiencies and strong cross-functional communication.
  • Partner with Global R&D to develop effective Nonclinical and Clinical strategies and protocols supporting new product development in accordance with regulatory requirements.
  • Work closely with colleagues across functions and commercial teams to provide timely regulatory support, driving growth of Galderma products.
  • Track and advise the company on the regulatory status of all products, recommending areas requiring further attention.
  • Collaborate with Medical, Legal, Commercial, and other teams to resolve regulatory concerns affecting distribution or promotional activities.
  • Lead staff by fostering an environment that encourages constructive feedback and coaching, aligning individual career goals with proactive developmental support.
  • Ensure department budget, including operating costs, is appropriately managed to plan.
  • Perform other duties as assigned.

Requirements

  • Bachelor’s degree from a four-year university is required; advanced degree preferred.
  • Minimum of twenty (20) years of experience in Pharmaceutical Regulatory Affairs.
  • Minimum of fifteen (15) years of experience reviewing clinical and nonclinical data in support of advertising and promotion of pharmaceutical products.
  • Minimum of ten (10) years of experience managing staff.
  • Extensive knowledge of laws and regulations applicable to developing, labeling, and promoting prescription drugs and medical devices.
  • Thorough working knowledge of the drug development process (pre-clinical, clinical, and product development), regulations related to submission through approval, and reporting/adverse drug reaction analysis.
  • Firm understanding of the content, review times, and fees for all regulatory submission pathways for drugs and devices.
  • Knowledge and understanding of clinical statistics, evaluation of clinical and non-clinical data, and how these aspects support medical, commercial, or statistical labeling and marketing.
  • Experience managing and collaborating in complex organizational structures, with demonstrated capability in influencing across such organizations.
  • Proven experience in successfully guiding complex regulatory strategies and ensuring effective implementation across the organization.
  • Demonstrated high degree of integrity, professionalism, and ability to establish credibility internally and externally.
  • High sense of urgency and commitment to execution.
  • Ability to handle confidential information and materials appropriately, in accordance with organizational policy and external regulations.
  • Excellent communication (verbal/written), interpersonal, organizational, and employee management skills.

Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Pay

The target base salary range for this role is $260,000–$365,000 per year. This range reflects anticipated compensation, with actual pay varying based on job responsibilities, skills, experience, education, certifications, location, market conditions, internal equity, and business considerations. In addition to base salary, this role is eligible to participate in an annual short-term and long-term incentive program, subject to plan terms and eligibility requirements.

Benefits

Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and other benefits, subject to eligibility and applicable plan terms.

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

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