Associate Director, Regulatory Affairs - Infant Formula
Nestlé Infant Nutrition (Gerber) is seeking a highly motivated Associate Director, Regulatory Affairs - Infant Formula to join the Medical Nutrition & Scientific Unit. The position is based in Florham Park, NJ and reports into the Sr. Director, Regulatory Affairs.
The Associate Director is responsible for ensuring that Nestle Infant Nutrition products (specifically Good Start Infant Formula) follow company policy and strategy while remaining in compliance with applicable FDA and USDA regulations. This position is also responsible for supporting claims development and substantiation; overseeing the regulatory change management process as related to the current and future infant formula product portfolio; advising on global projects as requested, and ensuring the regulatory compliance and technical accuracy of consumer and medical materials.
• Provide leadership and regulatory guidance and insights to the U.S. Nestle Infant Formula business.
• Partner cross functionally with Marketing and Product development to proactively identify and create opportunities for innovative product claims and positioning and influence the business strategy.
• Ensure that products are in compliance with local regulations with respect to product labeling and design.
• Ensure that all product claims and marketing materials are in compliance with local regulations, consistent with global policies, and are appropriately substantiated and documented.
• Ensure compliance of product formulations and ingredients nutrition information, and claims.
• Provide regulatory interpretation and guidance cross functionally to the business; specifically to product design, food ingredient approvals and marketing for appropriate product claims and advertising.
• Identify, assess and clearly communicate to the business any regulatory risks as well as recommended actions.
• Participate in the regulatory process and help influence key regulation and guidance.
• Manage the internal FDA submission development process for infant formula and work with Sr. Director of Regulatory Affairs in developing responses to FDA.
• Advise on regulatory aspects of factory controls and testing as well as product variances and compliance criteria.
REQUIREMENTS AND MINIMUM EDUCATION LEVEL:
• Bachelor's degree in Food Science, Nutrition, Chemistry or related discipline.
• Master's degree or PhD preferred.
• 8 years of experience with regulatory compliance or regulatory affairs management
• Regulatory Affairs, Nutrition, or R&D experience within the Infant Formula industry preferred
• Knowledge of global regulatory requirements is desirable
• Up to 10% domestic and international travel
• People management experience
• Strong project management, technical and communication skills.
• Very solid communication and negotiation skills.
• Ability to multi-task in a fast paced environment.
• Proactive, accountable and forward thinking.