Regulatory Affairs Associate - (Leonia, NJ)

Responsibilities: -Provide regulatory guidance to customers -An understanding of various aspects of a formula such as ingredients lists, quantitative formulas, exploded formulations (Decks), as well as multiple document types. -understand and put together portions or all of the Product Info Files (PIF’s) for the European Union. -Strong organization skills are a must. -Be able to communicate with customers, chemist and customer service personnel to provide advice, give project status info. -Review new raw materials against jurisdictional compliance. -Review formulas either using the Ithos IIN system or the PCPC International Raw Material Database. Qualifications: -Minimum BS Chemistry or related w/ approximately. four years regulatory exp. OR -MS Drug Regulatory Affairs, Chemistry or related science w/ 1-2yrs regulatory exp. -expertise to review and understand complicated regulatory rulings -understanding and exp. w/ ingredient lists, quantitative formulas, decks and product details files