Mgr, Regulatory Affairs, North America
Job DescriptionNovartis is a world leader in Medical Nutrition and pharmaceuticals, employing about 81,000 people and operating in over 140 countries around the world.
Novartis Nutrition offers many Medical Nutrition products and programs which results in enhancing, improving and saving lives.
This opportunity will: · Review claims, ingredients, processes, labels and product support for foods and medical devices to ensure compliance with United States and Canadian regulations.
· Manage and define the regulatory strategy and activities of the regional North American business unit to ensure harmonized, consistent policy and filings in support of the product portfolio.
· Effect government policy when needed.
· Review acceptability and compliance of new ingredients, products or processes with current or proposed regulations in North America.
This includes determining limits or nutrients that can be added and convening GRAS panels.
· Establish product classifications.
· In conjunction with Quality and Legal, act as the BU interface with FDA and Health Canada's regulatory agencies.
· Draft required responses to regulatory agencies for both foods and medical devices (483 response, recalls, device registrations, adverse event reports, dietary supplement claim notifications, etc.) · Serve as the key interface for all regulatory issues and questions related to product claims and substantiation.
o Provide regulatory guidance in the development of product claims options for new and existing products o Provide input to Legal and BU Management on regulatory risk assessments for proposed product claims.
o Review and approve all final product claims and supporting information.
o Maintain claims substantiation data files with information supporting all new and existing product claims.
· Manage the review and approval process for all product labels and all promotional materials prepared for public distribution (includes web-based information and Pocket Guide).
· Train individuals involved with labels and promotional pieces about USA and Canada food law regulations.
Create regulatory policies when needed.
· Keep Novartis senior management current on all regulatory rulings and positions that could impact product formulae and business in general.
Minimum requirementsExperience: Bachelors degree in Health Sciences or related field · Five to ten years work experience in Regulatory Affairs for US food company.
· In depth knowledge of US and Canadian retail regulations and labeling policies for both retail and medical food products.
· Experience with health claims development and risk assessment.
· Experience with both retail food and medical foods preferred.
· Experience with Medical Device regulations preferred Required years of experienceFive - Seven Years
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