Global Head of Injectable Aesthetics Regulatory Strategy
$260,000–$365,000 year
On-siteMiami, Florida, United States
Job Summary
Lead the development and execution of regulatory strategies to ensure the timely approval and launch of new injectable aesthetic products, including neurotoxins and fillers. Provide strategic guidance to ensure compliance with pre- and post-market regulations while managing successful interactions with regulatory agencies. Oversee the creation of procedures for clinical research submissions (INDs, IDEs) and marketing applications, and serve as the Global subject matter expert for local and global partners. Drive innovation by proposing viable projects that align with business needs and lifecycle management, while representing the Regulatory Affairs function on senior cross-functional committees. Manage activities related to field action, recall assessments, and adverse drug reaction reporting, ensuring effective collaboration with R&D, Medical, Legal, and Commercial teams to resolve regulatory concerns.
Required Qualifications
- Bachelor's degree from a four-year university
- Advanced degree
- Twenty (20) years of experience in Pharmaceutical Regulatory Affairs
- Ten (15) years of experience in the review of clinical and nonclinical data in support of the advertising and promotion of pharmaceutical products
- Ten (10) years of experience managing staff
- Extensive knowledge of the laws and regulations applicable to developing, labeling and promoting prescription drugs and medical devices
- 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
- Firm understanding of the content, review times and fees for all regulatory submission pathways for drugs and devices
- 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
- Experience managing and collaborating in complex organizational structures and demonstrated capability in collaborating and influencing across such an organization
- Effectiveness 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
- 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 in an appropriate manner, and in accordance to organizational policy, proper business practice, and/or appropriate external regulation/governance
- Excellent communication (verbal/written), interpersonal, organizational and employee management skills
- Ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams
- Occasional travel
Desired Qualifications
- Advanced degree
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