Global Head of Injectable Aesthetics Regulatory Strategy

About this role

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

The Opportunity The VP, Global Regulatory Strategy is responsible for leadership and management of the Global Regulatory Affairs Injectable Aesthetics team including the development and execution of successful regulatory strategies for all injectable aesthetic products including neurotoxins, fillers and other medical devices.

The VP, Global Regulatory Strategy will provide strategic and technical guidance to ensure compliance by the company with regulations for products in development, to ensure timely approvals occur, and those marketed, to ensure business continuity can occur. These responsibilities will be made possible through the creation and management of procedures and processes that ensure compliance with pre- and post-market product regulations and standards while also managing successful regulatory agency interactions.

Key Responsibilities • Responsible for leading the development and execution of regulatory strategies to ensure the timely and successful approval and launch of new products as well as changes to marketed products. Regulatory pathways will take into account strategic opportunities, optimal business needs and lifecycle management.

• Provides oversight and critical input to Global R&D colleagues to assist the creation and management of key submission types including those to support clinical research (INDs and IDEs) and new marketing applications and related Variations, Supplements and Amendments.

• Serves as the Global subject matter expert in giving guidance to local and global partners while considering companywide implications. Supports and advises company on regulatory requirements for acquisition integration and new product development.

• Drives innovation by utilizing knowledge of business needs and regulations to propose innovative yet viable projects that fit company strategy.

• Represents the Regulatory Affairs function on the Injectable Aesthetics Steering Committee and other senior level cross-functional committees. Responsible for leading activities related to field action and recall assessment processes and related communications to regulatory authorities.

• Leads the collaboration with regulatory team and other functions in the creation and maintenance of procedures and tools that ensure functional efficiencies and strong cross-functional communications. 

• Partners with Global R&D partners to develop effective Nonclinical and Clinical strategies and protocols to support new product development in accordance with regulatory requirements.

• Works closely with colleagues in the various functions and commercial to provide timely regulatory support to help drive growth of Galderma products.

• Tracks and advises the company of the ongoing regulatory status of all products including making recommendations for areas requiring further attention.

• Works closely with Medical, Legal, Commercial and other Galderma team members to resolve any regulatory concerns that could affect distribution or promotional activities.

• Leads staff while creating an environment that encourages constructive feedback and coaching; considers individual career goals and aspirations; and provides proactive developmental support for employees.

• Ensures that department budget, including operating costs, is appropriately managed to plan.

• Other duties may be assigned.

Qualifications • Bachelor's degree from a four-year university is required; advanced degree preferred.

• Minimum of twenty (20) years of experience in Pharmaceutical Regulatory Affairs is 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 is required. 

• Minimum of ten (10) years of experience managing staff is required. 

• Extensive knowledge of the laws and regulations applicable to developing, labeling and promoting prescription drugs and medical devices is required.

• Must have thorough working knowledge of the drug development process (pre-clinical, clinical, and product development), regulations and process related to submission through approval, and regulations for reporting and analyzing adverse drug reactions.

• A firm understanding of the content, review times and fees for all regulatory submission pathways for drugs and devices is 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 is required.

• Experience managing and collaborating in complex organizational structures and demonstrated capability in collaborating and influencing across such an organization is required.

• Must be effective at developing and cultivating relationships with FDA and other regulatory agencies.

• Must have proven experience in successfully guiding complex regulatory strategies, ensuring effective implementation across the organization, is required.

• Must have demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally.

• Must have high sense of urgency and commitment to execution.

• Must be able to handle confidential information and materials in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance.

• Must demonstrate excellent communi

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