Global Head of Injectable Aesthetics Regulatory Strategy

Galderma•Miami, FL

1d•Hybrid

About The Position

Galderma is seeking a VP, Global Regulatory Strategy to lead and manage the Global Regulatory Affairs Injectable Aesthetics team. This role is responsible for developing and executing regulatory strategies for all injectable aesthetic products, including neurotoxins, fillers, and other medical devices. The VP will provide strategic and technical guidance to ensure company compliance with regulations for products in development and on the market, ensuring timely approvals and business continuity. This will be achieved through the creation and management of procedures and processes that ensure compliance with pre- and post-market product regulations and standards, as well as managing successful regulatory agency interactions.

Requirements

Bachelor's degree from a four-year university is required.
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.
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.
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 with organizational policy, proper business practice, and/or appropriate external regulation/governance.
Must demonstrate excellent communication (verbal/written), interpersonal, organizational, and employee management skills.
External applicants must be eligible to work in the United States.

Nice To Haves

Advanced degree preferred.

Responsibilities

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, considering strategic opportunities, optimal business needs, and lifecycle management.
Providing oversight and critical input to Global R&D colleagues for the creation and management of 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 innovative yet viable projects that fit 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 related communications to regulatory authorities.
Leading the collaboration with the regulatory team and other functions in the creation and maintenance of procedures and tools that ensure functional efficiencies and strong cross-functional communications.
Partnering with Global R&D partners 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 to drive growth of Galderma products.
Tracking and advising the company on the ongoing regulatory status of all products, including making recommendations for areas requiring further attention.
Working closely with Medical, Legal, Commercial, and other Galderma team members to resolve any regulatory concerns that could affect distribution or promotional activities.
Leading staff, creating an environment that encourages constructive feedback and coaching, considering individual career goals and aspirations, and providing proactive developmental support for employees.
Ensuring that the department budget, including operating costs, is appropriately managed to plan.
Performing other duties as assigned.