Senior Specialist, Regulatory & Compliance

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Lonza in Greenwood, SC is looking for an experienced Senior Regulatory & Compliance Specialist! As our Senior Regulatory & Compliance Specialist, you are responsible for all regulatory activities as it pertains to our Dosage Form Solutions (DFS) business.

Key responsibilities:

• Providing an accurate and timely response to customer requests relating to regulatory and compliance requirements as it relates to products manufactured by DFS (Dosage Form Solutions) operations (i.e. to support new or reformulated product launches, change of ingredients sources, and requests for regulatory documentation).
• Responsible for acquiring and maintaining all regulatory registrations and notifications vital to obtain authorizations for the applicable activities.
• Be the primary contact for site authority inspections or regulatory authority inquiries.
• Responsible for supervising regulatory and compendium changes that impact the DFS business and aiding in action plan development for compliance.
• Ensure accurate regulatory assessments of raw materials and formulas are performed.
• Responsible for risk assessment and mitigation activities related to potential product recalls.
• Provide support for raw material qualification, by resolving compliance deliverables for the intended scope such as appropriate regulatory and quality standards, and specific compliance declarations such as harmful substances, GMO, gluten, allergens, etc.
• Provide mentorship on labeling, which includes the development of Supplement Facts panels, in compliance with US FDA regulations.
• Drive efficiencies in current processes to ensure regulatory and compliance aspects are accurately captured.
• Partner with business leaders and Regulatory leadership ensuring all projects are appropriately prioritized, goals are met on time, and commercial/customer support is delivered.

Key requirements:

• Bachelor’s degree in chemistry, biology, or related field required.
• Significant experience working in the dietary supplement or food industry.
• Experience in regulatory affairs.
• Solid understanding of 21 CFR 117 Requirements for Human Food and 21 CFR 111 requirements for Dietary Supplements.
• Excellent communication skills both oral and written to actively support customers and authority requests.
• Experience in FDA dietary supplement labeling
• Experienced in regulatory inspections and interactions with FDA.
• Significant experience in Microsoft Office skills (including Excel, PowerPoint, etc.).

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.