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Job #03597

About our client Our client develops and produces a wide variety of personal care, nutrition and technology products worldwide. They have a large number of marketed products which has helped them to maintain a strong global presence. They are dedicated to the personal and professional growth of their employees and this is an excellent opportunity for the right person. Position Location Director of Regulatory Affairs Utah Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate with product registration specialists to understand regulatory qualifications for all markets 2) Report compliance issues to PD General Counsel with any legal and trade regulation implications for advertising and claims in all markets 3) Help to coordinate the regulatory review and compliance of product labels 4) Work with R&D scientists with new product formulations and reformulation of existing product to meet international regulatory requirements 5) Work with the Marketing Team to ensure all aspects of marketing literature comply with country laws and regulations 6) Report to PD General Counsel for any use of outside counsel for regulatory issues in countries where necessary to complete job functions 7) Train Regulatory Team as to effective practices in regulatory affairs management, record keeping and uniform operating procedures 8) Help them improve their performance, growth and increase global regulatory knowledge base 9) Work proactively in new idea phase to assist in bringing new and unique technologies and claim to the team for evaluation 10) Keep current on changes in regulations, advertising and claims guidelines, etc. 11) Read regulations, legal opinions, trade journals, attend regulatory seminars and industry conferences 12) Attend cross functional meeting to help coordinate, plan and discuss ways of effectively working with other functional heads 13) Coordinate with Quality Assurance to ensure compliance with all cGMP requirements 14) Help ensure NSE cGMP compliance and readiness for FDA cGMP inspections 15) Assist Senior Director in establishing a strategic plan for Regulatory Affairs Department 16) Partner and assist international market regulatory staff with timely product registration including outside consultants 17) Assist with the serious adverse event reporting as required by the US FDA and the other markets which have similar requirements Requirements 1) BA or BS with 8 – 10 years of experience in regulatory affairs, science, paralegal/legal assistant 2) 3 years of supervisory or management experience 3) Experience in Global Product Registration (EU), Global Product Labeling and launching new product in global market 4) Experience in and exposure to trade associations and expert committees 5) In-depth knowledge of regulations, laws, policies and guidelines regarding food, dietary supplements, OTC drugs and cosmetics 6) Good understanding of the US regulatory process and international/foreign regulatory affairs 7) In-depth understanding of the product development process with respect to marketing, technical production and quality 8) Ability to keep commitments and deliver under pressure, demonstrate creativity and innovation in an intelligent way 9) Ability to take calculated risks and appropriate initiative 10) Ability to take responsibility for job assignments and for errors 11) Ability to deliver in a timely manner 12) Demonstrated leadership and innovation in previous levels 13) Willingness and ability to travel to foreign countries