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. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

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. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold 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 Global Head of Injectable Aesthetics 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 Global Head of Injectable Aesthetics 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 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.

This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.

What We Offer

At Galderma, you’ll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.

Next Steps

If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

The next step is a virtual conversation with the hiring manager

The final step is a panel conversation with the extended team

Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!

If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers . Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment.

All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.