Sr Specialist, Regulatory

Sr Specialist, Regulatory & Compliance (Dietary Supplements Industry)At Lonza, we believe that our greatest scientific solution is talented people working together to devise ideas that help businesses help people. We offer a unique work environment where employees own their careers and can genuinely improve the world.Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.Lonza in Greenwood, SC seeks an experienced Senior Regulatory & Compliance Specialist for our Dosage Form Solutions (DFS) business.Key Responsibilities:Provide timely and accurate responses to customer requests regarding regulatory and compliance requirements for products manufactured by DFS operations.Acquire and maintain all necessary regulatory registrations and notifications for product launches, ingredient changes, and documentation.Serve as primary contact for site authority inspections and regulatory inquiries.Supervise regulatory and compendium changes impacting the DFS business and aid in developing action plans for compliance.Ensure accurate regulatory assessments of raw materials and formulas are performed.Conduct risk assessment and mitigation activities related to potential product recalls.Support raw material qualification by resolving compliance deliverables.Provide mentorship on labeling, including Supplement Facts panels, in compliance with US FDA regulations.Drive process efficiencies to ensure regulatory and compliance aspects are accurately captured.Collaborate with business leaders and Regulatory leadership to prioritize projects, meet goals, and deliver commercial/customer support.Key Requirements:Bachelor's degree in chemistry, biology, or related field.Significant experience working in the dietary supplement or food industry.Experience in regulatory affairs.Familiarity with 21 CFR 117 Requirements for Human Food and 21 CFR 111 requirements for Dietary Supplements.Excellent communication skills for supporting customers and authority requests.Experience in FDA dietary supplement labeling.Experienced in regulatory inspections and interactions with FDA.Strong Microsoft Office skills (including Excel, PowerPoint).We strive to make a positive impact on millions of people every day. Our business results are just as important as achieving them ethically. At Lonza, we respect and protect our people and environment.Careers at Lonza offer the challenge and creativity of solving complex problems and developing new ideas in life sciences.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to protected characteristics.

Created: 2025-03-06