Global Head of Injectable Aesthetics Regulatory Strategy

Galderma•Miami, FL

7d•$260,000 - $365,000•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 committed to advancing dermatology for every skin story and look for individuals who are results-oriented, eager to learn, and bring positive energy, initiative, teamwork, and collaboration. Passion for making a meaningful impact is essential. We aim to empower employees, promote personal growth, and ensure business needs are met. Diversity, dignity, privacy, and personal rights are respected across the company. At Galderma, we provide opportunities for challenging work experiences and direct impact, supporting our bold ambition to be the world's leading dermatology company.

Requirements

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

Nice To Haves

Advanced degree preferred.

Responsibilities

Leading the development and execution of regulatory strategies for timely and successful approval and launch of new products 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, and supporting regulatory requirements for acquisition integration and new product development.
Driving innovation by proposing viable projects that align with company strategy, utilizing knowledge of business needs and regulations.
Representing the Regulatory Affairs function on the Injectable Aesthetics Steering Committee and other senior-level 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 for new product development in accordance with regulatory requirements.
Working closely with 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, making recommendations for areas needing attention.
Working closely with Medical, Legal, Commercial, and other Galderma team members to resolve regulatory concerns affecting distribution or promotional activities.
Leading staff by creating an environment that encourages constructive feedback and coaching, considering individual career goals, and providing proactive developmental support.
Ensuring appropriate management of the department budget, including operating costs, according to plan.
Performing other duties as assigned.