MAIN JOB OBJECTIVE
The Regulatory Director is to lead and ensure the global regulatory compliance by working with central and local teams, and to define, develop and implement process for performance improvement.
- Closely work with R&I (Regulatory, Formula development, Product safety...) and Product development teams to manage product regulatory of internal and external development. This includes but is not limited to:
- Review raw material and ingredient compositions for regulatory conformity based on industry guidelines/international restrictions, provide guidance as necessary
- Monitor and ensure product stability, compatibility, micro, safety, usage and regulatory requirements. Create/design/review product testing requirements as necessary.
- Propose, review and validate artwork/product claims when necessary
- Assist product registration as needed
- Assess needs, set strategies, develop and maintain internal procedures for regulatory compliance, product safety and performance improvement, assist internal teams for implementation
- Maintain regulatory standards and protocols to ensure compliance with various international regulations, work with country Regulatory teams for country regulatory, safety, claims... topics/projects
- Provide guidance on regulatory compliance related to the development, testing, registration, sourcing, packaging, labeling, manufacturing, transport and sale of OTC drugs and cosmetics. Assist team with impact analysis and propose solutions to maximize the business benefit and maintain regulatory compliance
- Support R&I on OTC product development and compliance needs. Manage FDA OTC drug regulatory activities, collaborate with Operations on issues related to regulatory quality, and provide guidance on compliance risks.
- Manage health-related complaints (cosmeto-vigilance) with R&I collaboration, to analyze, trend and recommend appropriate actions
- Participate in industry committees, notify regulatory changes and take corresponding actions
- Liaise with government regulatory bodies and administrative agencies on behalf of the company regarding product issues, inspections, and inquiries
- Bachelors of Science Degree required - Chemistry background is preferred
- Minimum of 10-15 years regulatory experience in the cosmetic industry
- Minimum 5 years' experience in OTC drug regulations with relevant experience in OTC quality regulatory requirements
- Strong knowledge of the cosmetic industry, formulations, packaging, labelling and manufacturing practices.
- Solid knowledge of global cosmetic and drug product regulations (FDA, DIN...), GMP's, Federal EPA and US state environmental regulations, as well as EU, Canada and Asia international cosmetic regulations
- Experience in cosmetic product compliance and international product registrations
- Experience interacting with governmental agencies
- French language skills are desired but not required
- Knowledge in Sustainability regulations is a plus
- Strong interpersonal and communication skills, to be able to deal effectively with all levels of internal and external partners
- Excellent organization and prioritization skills
- Leadership and autonomy
- Detail-oriented and process driven.
- Proficiency at conveying information in a clear, focused and concise manner.
15% travel required
Located in Jersey City, NJ