Regulatory and Compliance Specialist at US26 Capsugel Manufacturing LLC in Greenwood, South Carolina

Job Description:

Today, Lonza is a global leader in life sciences operating across three 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 Regulatory & Compliance Specialist.  As our 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 product development and qualification, change of capsule supplier or ingredients source, and applicable regulations as it relates to products manufactured by DFS (Dosage Form Solutions) operations. 


• Responsible for obtaining and maintaining all regulatory registrations and notifications necessary to obtain authorizations for the applicable activities.


• Be the primary contact for site authority inspections or authority inquiries.


• Responsible for monitoring regulatory and compendial changes that impact the DFS business and aiding in action plan development.


• Ensure relevant documentation is maintained as part of the quality system and regulatory requirements.


• Responsible for risk mitigation activities related to potential product recalls.


• Ensure regulatory assessment of raw materials are performed and responsible for development and maintenance of purchasing/product specifications for DFS raw materials and finished products.


• Perform end to end impact assessments.

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.


• Excellent communication skills both oral and written to actively support customers and authority requests.


• Working knowledge of 21 CFR 111 requirements for Dietary Supplements.


• Experienced in regulatory inspections and interactions with FDA.


• Experience with DEA quotas, ARCOS reporting and YERS reporting.


• 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.