Global Head of Injectable Aesthetics Regulatory Strategy

Galderma•Miami, FL

1d•Hybrid

About The Position

Galderma is a leading company in the dermatology category, operating in approximately 90 countries. We offer an innovative, science-based portfolio across Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since 1981, we have focused on skin health, meeting individual needs with superior outcomes in partnership with healthcare professionals. We are looking for individuals who are results-oriented, eager to learn, and bring positive energy, combining initiative with teamwork. Passion for making a meaningful impact on consumers, patients, and healthcare professionals is essential. We aim to empower employees and promote personal growth while meeting business needs, embracing diversity, and respecting individual dignity. At Galderma, we provide opportunities for challenging work experiences and direct impact, aiming to be the world's leading dermatology company.

Requirements

Bachelor's degree from a four-year university (advanced degree preferred).
Minimum of twenty (20) years of experience in Pharmaceutical Regulatory Affairs.
Minimum of fifteen (15) years of experience in the review of clinical and nonclinical data supporting 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, product development), submission through approval processes, and regulations for reporting and analyzing adverse drug reactions.
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 support medical, commercial, or statistical aspects of labeling and marketing.
Experience managing and collaborating in complex organizational structures, with demonstrated capability in influencing across such an organization.
Effectiveness in developing and cultivating relationships with FDA and other regulatory agencies.
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.
Excellent communication (verbal/written), interpersonal, organizational, and employee management skills.

Nice To Haves

Advanced degree preferred.

Responsibilities

Leading the development and execution of regulatory strategies for timely and successful approval and launch of new injectable aesthetic products (neurotoxins, fillers, medical devices) and changes to marketed products, considering strategic opportunities, business needs, and lifecycle management.
Providing oversight and critical input to Global R&D colleagues for key submission types, including INDs, IDEs, new marketing applications, and related Variations, Supplements, and Amendments.
Serving as the Global subject matter expert, providing guidance to local and global partners with consideration for company-wide implications.
Supporting and advising the company on regulatory requirements for acquisition integration and new product development.
Driving innovation by proposing viable projects that align with company strategy, leveraging knowledge of business needs and regulations.
Representing the Regulatory Affairs function on the Injectable Aesthetics Steering Committee and other senior cross-functional committees.
Leading activities related to field action and recall assessment processes and communications to regulatory authorities.
Leading collaboration with the regulatory team and other functions to create and maintain procedures and tools for functional efficiencies and strong cross-functional communication.
Partnering with Global R&D to develop effective Nonclinical and Clinical strategies and protocols to support new product development in accordance with regulatory requirements.
Working closely with colleagues in various functions and commercial teams to provide timely regulatory support for product growth.
Tracking and advising the company on the ongoing regulatory status of all products, recommending areas for attention.
Working closely with Medical, Legal, Commercial, and other Galderma team members to resolve regulatory concerns affecting distribution or promotional activities.
Leading staff, fostering an environment of constructive feedback and coaching, considering individual career goals, and providing proactive developmental support.
Ensuring appropriate management of the department budget, including operating costs.