Regulatory Affairs Specialist
4 weeks ago
Our client is currently seeking a Regulatory Affairs Specialist for a 12 month + contract.
**Experience with Optiva, or similar formula management system would be a plus like GENESIS**Regulatory Analyst with emphasis on ingredients. This role advises the R&D, global procurement and businesses on the safe use, regulatory compliance and labeling of food ingredients. This includes reviewing all ingredients purchased by the company, with consideration of how they are manufactured and how they are intended to be used from a regulatory perspective. 1.Evaluate new ingredients and technologies for regulatory compliance against applicable US and Canadian food regulations. 2. Provide input to ingredient specifications in a way that assures ongoing regulatory and internal compliance. 3. Determine labeling terms to be used for finished products with consideration of business needs for transparency 4. Respond to internal and external customer inquiries regarding use and function of ingredients 5. Resolve regulatory questions with suppliers during the ingredient and formula review process so that business and Quality needs are addressed prior to approval and use.6. Work closely with Toxicologist to oversee externally contracted safety evaluations for ingredients to support technical, marketing and regulatory and/or nutrition-related initiatives. 7. Gather regulatory and nutrition-related ingredient information for use in product information databases or as part of corporate social responsibility indices. 8. Manage documentation to preserve integrity of files needed to substantiate labeling with regulatory agencies. General knowledge of the regulatory landscape (e.g., regulations, issues) that may affect the food industry. This includes knowledge of the major regulatory issues facing the industry. • Participate on internal regional and global cross-functional teams working on innovation across the entire portfolio and provide input and guidance to minimize scientific and regulatory barriers. • Familiarity with common food formulations and manufacturing processes. • Ability to manage projects to ensure successful delivery (on time, within budget, meeting agreed upon success criteria) to establish clear goals and accountabilities. • Advise and educate internal stakeholders by disseminating key facts and presenting complex information in a concise and easy-to-understand manner. Use technical and business expertise to explain difficult concepts to technical and non-technical audiences, tailoring communications to meet each.REQUIRED: B.S. food science, nutrition, chemistry or related OR M.S. food science, nutrition, chemistry or related 1+ year experience with pharma/food ingredients and formulations in an industry or government setting
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