Regulatory Specialist, Health & Nutrition
United States, Morristown (New Jersey)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.
The Regulatory Specialist, Health & Nutrition will be responsible for capturing and surveilling regulatory requirements for Lonza's Healthcare Product Portfolio dedicated to the nutrition market in the United States, for food, dietary supplement, feed or any other related application. Collaborative with operational quality teams, install systems with the aim to ensure continued compliance. To be main point of contact for regulatory support for external and internal customers (Commercial/R&D/Marketing/Quality), and leverage regulatory compliance as business value. Sustain market recognition as a compliant business partner in a regulated environment.
- Actively support market and authority requests with the aim to secure customer satisfaction and regulatory compliance, via:
- Timely providing professional and satisfactory solutions to any customer/authority request related to applicable standards and regulations.
- Translating market feedback to meaningful trends as input for action programs to increase satisfaction
- Presence at customers for technical or regulatory support where needed
- Supports marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives. In this context, following activities:
- Leverage regulatory compliance as business value, actively participating with sales and marketing.
- Prepare regulatory assessments for Americas, on regionally and globally relevant topics of interest
- Prepares business impact assessments for emerging regulatory topics
- Actively supports and reviews marketing and R&D publishing material / develop and maintain appropriate internal and market support tools.
- To anticipate and capture regulatory evolutions, documented via a pragmatic impact assessments and centralized in an overview database, for following (non-limiting) areas of interest:
- Legislative evolutions and industry guidance in the domain of nutrition, with focus on empty capsules and related ingredients, as dosage forms for dietary supplements
- Overall food/feed GMP and manufacturing standards requirements
- Translate applicable regulations or guidelines into comprehensive action plans and ensure proper implementation
- Maintain solid professional relationships with external stakeholders in the industry in order to identify trends and opportunities and to ensure involvement in authority interactions for new or evolving legislation.
- Support collaboration with regulatory and certification bodies to ensure solutions for market requirements and to maintain required certifications and registrations.
- Bachelor’s or Master’s Degree in Chemistry, Biosciences, Nutritional Sciences, Biotechnology or similar through experience
- Working experience in Regulatory and/or Quality responsibilities in Food/Dietary Supplement or Healthcare industry
- Strong communication skills (verbal & written)
- Strong analytical skills and structured approach to problem solving
- Capability to perform end to end impact assessments taking overall business strategies into account
- Capability to translate complex matter in comprehensive summaries
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.