Senior regulatory affairs manager

Pharma Search Partners, Inc.; South Carolina; On-site; USD 110,000 - 150,000; Full time

Job summary

Pharma Search Partners, Inc. is seeking a Senior Regulatory Affairs Manager in South Carolina to lead regulatory activities for FDA labeling compliance.

The role requires at least 5 years of regulatory experience in the food industry and a Bachelor’s degree in food science or related discipline. You will review ingredient statements, nutritional panels and product specifications for new and existing products, ensuring CFR Title 21 compliance, and collaborate with internal departments to meet

Qualifications

• Expert knowledge of CFR Code of Federal Regulations - Title 21 (FDA).
• Deep understanding of food labeling regulations and customer requirements.
• Strong analytical skills and attention to detail.
• Proficient in MS Excel and data management.

Responsibilities

• Provide deep technical support for FDA and labeling compliance.
• Review raw material specifications, formulations, and labels for regulatory compliance.
• Develop nutritional panels, ingredients statements and product specifications for new products and verify existing data.
• Proofread final artwork and ensure packaging adheres to regulations.

Education

Bachelor's in Food Science

Tools

Nutrition software

Job description

Please review the listings below of currently available job openings.

We are currently hiring a well-roundedSenior Regulatory Affairs Manager

Position Responsibilities

• Provide deep technical support for FDA and Labeling Compliance.
• Review and assess Raw Material Specifications, Formulations, and Food Labels for Compliance with applicable Government Regulations, NC standards and Customer Requirements.
• Develop nutritional panels, ingredients statements and product specifications for all new products as well as review and verify nutritional and ingredient information of existing products ensuring data is current and accurate meeting CFR Code of Federal Regulations- Title 21- FDA.
• Respond to Technical requests from customers, portals, and questionnaires.
• Support All NC company Art Dept. Initiatives and Requests. Review and verify nutritional and ingredient information of existing products ensuring data is current and accurate. Proofread final mechanicals received from the art department prior to print.Work closely with internal departmentsto ensure that all product labeling and packaging plans adhere to company policy and federal regulations.
• Maintain electronic project folders and accounts details. Compile data and documents accordingly for the development of individual product specification sheets and raw material specifications as needed.
• Support the ongoing development of FDA regulations and Customer requirements.
• Work on other projects as assigned by the Operations Manager and VP.

Other Competencies:

• Expert knowledge of CFR Code of Federal Regulations- Title 21- FDA
• Expertise in laws and regulations governing product labeling.
• Highly detail oriented withSuperior proofreading, organizational, time management and analytical skills.
• Assist Regulatory Affairs, Operations Manager with projects as assigned.
• Work with TEAM on priority projects as needed.
• Continual assessment of processes and recommend best practices.
• Self- Starter with the ability to multi-task in a very fast-paced environment.
• Proficient in MS Excel, Word; nutrition software a plus.
• Able to communicate technical and regulatory information to broad audiences.
• Bachelor’s degree in food science or related discipline
• Well-developed written and verbal communication skills and ability to translate (English/Spanish) a plus.
• Minimum of 5 years of experience in a regulatory capacity, preferably in the food industry.
• Expert knowledge of Food Regulatory. Knowledge of NON-GMO Project Verified a plus.
• Numerical and analytical aptitude
• Highly detail oriented
• Well-developed organizational, follow up and discipline skills.
• PC literacy – proficient in database and spreadsheet software
• Ability to multi-task and take charge of projects.