Regulatory Affairs Specialist
Compensation: $111,200.00 - $80,990.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
Regulatory Affairs Specialist - Temp to Hire Contract (24.00 per hour) Please come join a local food technology company. Duties:
- Drafting and coordinating responses to questions from regulatory authorities to obtain regulatory approvals in support of product launches in key markets.
- The Regulatory Affairs Specialist may provide support to the retrieval of regulatory codes that support business development needs and secure products successful launch to market. Including managing full NPD and launching processes.
- Provide support to customs, harmonized tariff numbers, international pre-notification imports, providing supply chain guidance when necessary for supplies and finished products.
- To collectedly prepare customer documentation to satisfy customer requests. This function requires knowledge of specific customer and US FDA Food/Flavor State Regulations. Specific documents include: customer questionnaires, natural certification, FDA/FEMA-GRAS Certifications, allergen, food-grade, and GMO certification, continuing food guarantee, country of origin, nutritional, organic, Kosher, Halal, country permissibility and other appropriate documents.
- Support management in other regulatory tasks, including special projects. Identify areas of improvement and increased efficiency.
- Update BRC procedures for the continuous improvement process. Interface with Sales Team, Production, Quality Control and affiliates to satisfy customer requests.
- Review U.S. product labels including ingredient statements, nutrition facts, nutrient content claims, health claims, and other statements provided on label for regulatory compliance.
- Acting independently to anticipate needs, studying issues, identifying options, and offering compliance solutions.
- Building effective relationships with key stakeholders, ensure effective communication, information flow, and effective issue-resolution.
- Preparing documents, executive summaries, and presentations to senior leadership and regulatory agencies to accomplish goals.
- Compiling, researching, managing and archiving information.
- Assist the Regulatory Team with process improvement and data management, including the development and maintenance of labeling checklists, brand reference guides and SOPs.
- Summarize and review microbiological data to meet regulatory reporting requirements.
- Monitor and track current regulations and warning letters related to food labeling, nutrition, claims and food safety.
- Collaborate and facilitate collaborations across multi-disciplinary teams.
- Organizing meetings and coordinating or leading the activities of others.
College degree (B.S.) in Food Science, Food Technology, Food Chemistry, Nutrition or related fields
3 to 6 years of experience in the flavor and or food industry group.
- This position has detailed knowledge in regulatory issues and interpretation of regulations and legal affairs. Knowledge of basic chemistry and mathematics essential.
- Proficiency in submitting or supporting regulatory submission including FEMA FDA GRAS but not lined to international bodies.
- Superb organizational skills and high attention to detail.
- Demonstrated excellent judgment and common sense.
- Strong critical thinking, analytical and problem-solving skills.
- Desire to excel and grow within the Regulatory team.
- Ability to adapt to shifting priorities and manage multiple projects with competing deadlines.
- Proficient in MS Office Product, SalesForce Client Management Systems and ERP like
- The ideal candidate will bring two years of regulatory experience and technical skills writing, GRAS submission writing preferred.
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Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.Job Requirements:
Associated topics: dietician, disease, food, health, kinesiology, medicine, nephrology, pharmaceutical, pharmacometrics, therapy
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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