Regulatory Affairs Senior Specialist

PURPOSE Provide regulatory support for the successful domestic and international commercialization of consumer products (primarily personal care, OTC drugs and cosmetics).

ESSENTIAL JOB FUNCTIONS Support the daily operations of the regulatory department. Review and approve artwork for international regulatory compliance. Screen formulae for restricted or prohibited ingredients against global regulations. Communicate and apply safety recommendations to global packaging. Manage the preparation of dossier packages for formula registration and international regulatory filings. Interact with international regulatory agencies, external consultants, and cross-functional teams to ensure compliance of formulas, ingredient listings and artwork copy. Prepare filings for international natural personal care certifications. Assist in thought leadership for Regulatory Affairs department through the development/improvement of internal practices.

MINIMUM RECRUITMENT STANDARDS BA/BS Degree in Chemistry or Biology or similar discipline is required. A minimum of four (4) years of related and progressively responsible regulatory experience. Demonstrated understanding of global cosmetic and OTC regulatory requirements. Demonstrated effectiveness in interactions with the international regulatory agencies. Working knowledge of FDA regulations, including OTC monographs. Working knowledge of EU cosmetic regulations. Working knowledge of various Asian cosmetic regulations. Working knowledge of Health Canada regulations. Demonstrated experience maintaining excellent work relationships with internal and external contacts. Candidate must be resourceful and flexible Candidate must possess: Excellent verbal, written, and organizational skills. Demonstrated ability to think analytically, creatively and strategically. Ability to work on multiple tasks simultaneously, manages time efficiently, and works with minimal supervision. Advanced Microsoft Office computer skills, including Microsoft Word, Access, Excel, and PowerPoint are a must.

EOE/AA M/F/D/V
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