Global Head of Injectable Aesthetics Regulatory Strategy

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 a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day.

About the role

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 role provides 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.

Responsibilities

• Lead 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.
• Provide 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.
• Serve as the Global subject matter expert in giving guidance to local and global partners while considering companywide implications.
• Support and advise the company on regulatory requirements for acquisition integration and new product development.
• Drive innovation by utilizing knowledge of business needs and regulations to propose innovative yet viable projects 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 and related communications to regulatory authorities.
• Lead 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.
• Partner with Global R&D partners to develop effective Nonclinical and Clinical strategies and protocols to support new product development in accordance with regulatory requirements.
• Work closely with colleagues in various functions and commercial to provide timely regulatory support to help drive growth of Galderma products.
• Track and advise the company of the ongoing regulatory status of all products, including making recommendations for areas requiring further attention.
• Work closely with Medical, Legal, Commercial, and other Galderma team members to resolve any regulatory concerns that could affect distribution or promotional activities.
• Lead staff while creating an environment that encourages constructive feedback and coaching; consider individual career goals and aspirations; and provide proactive developmental support for employees.
• Ensure that 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 is required.
• Minimum of fifteen (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.
• Effective at developing and cultivating relationships with FDA and other regulatory agencies.
• Proven experience in successfully guiding complex regulatory strategies, ensuring effective implementation across the organization, is required.
• Demonstrated high degree of integrity, professionalism, and the 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, proper business practice, and/or appropriate external regulation/governance.
• 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 requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Pay

The target base salary range for this role is $260,000-$365,000 per year. This range reflects the anticipated compensation for the role. Where pay falls within the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location, and applicable geographic pay zones, market conditions, internal equity, and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors. 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.