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The Senior Manager, Regulatory Affairs has overall responsibility for providing technical regulatory input to cross-functional project teams for all project activities. Implements regulatory strategies and keep the product within compliance. The professional must possess ability to solve practical problems and deal with a variety of situations in a fast paced environment. Ability to interpret FDA and USDA CFR with respect to its impact on national programs, regional programs and product labeling.
- Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management to define regulatory strategies.
- Provide regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines.
- Act as regulatory lead for the review of documentation prepared by other technical functions
- Provide regulatory review and approve of internal documentation supporting product development activities
- Coordinate labeling revisions and the scheduling of receipt of Final Printed Labeling (FPL) with the Label Control Departments.
- Creation and oversight for maintenance of regulatory project logs, tracking the submission status of reports and other regulatory activities
- Monitor the development of new requirements or regulatory procedures
- Responsible for the maintenance of a database to track the labeling history of each product.
- Assist in the preparation of new and revised product labeling. This includes: creating original electronic labeling; revising existing labeling in response to FDA and/or USDA comment, to make minor or editorial changes, or as a result of changes in FDA/USDA regulations.
- Assist in communications with Regulatory Agencies
- Bachelor’s degree (scientific, nutrition or food science background desirable) required.
- Minimum of 5 years of experience in the food industry
- Understanding of the Title 21 of the Code of Federal Regulations, Title 9 of Code of Federal Regulations, various FDA Guidance’s for Industry, various USDA Guidance’s for industry along with knowledge of the regulatory process.
- Problem solving – the individual identifies and resolves problems in a timely manner, gathers and analyzes information skillfully.
- Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter
- Complete attention to detail – the individual demonstrates a high degree of accuracy and thoroughness, very detailed oriented, monitors own and team work to ensure quality.
- Proficiency in MS Office Suite applications
- Good verbal and written communications skills.