Senior Regulatory Affairs Professional
Lonza’s Capsules & Health Ingredients business is the trusted partner for innovative products, including capsules and health ingredients, customization services and end-to-end dosage form solutions for pharmaceutical and nutraceutical companies.
Bornem, Belgium | Lonza is looking for an experienced regulatory affairs specialist to provide expert regulatory advice/guidance to the CHI R&D Division, business development and marketing teams.
- ensure compliance of new initiatives and product developments with regulatory requirements.
- preparing regulatory assessments for regionally and globally relevant regulatory topics of interest
- leveraging regulatory compliance as business value support
- Coordinate with business leaders and RA leadership to ensure all projects are appropriately prioritized, key goals are met on time, and customer support is delivered.
- Provide general regulatory support for pharmaceutical and nutrition applications of both operative product portfolio and innovative products/technologies by addressing internal/external customer inquiries in a timely manner.
- Manage the coordination, preparation, submission and follow up of regulatory product registrations, including the coordination of any necessary supporting studies and management of regulatory or substance related issues. New studies and any advocacy to manage events may require close coordination with RA Leadership, CHI Marketing/Strategy, R&D, legal and Product Safety and Toxicology as appropriate.
- Gain and maintain expertise in relevant regulations and guidelines to ensure delivery of a high standard of support.
- Master degree or similar in pharmacy, chemistry, bio engineering, biotechnology, food technology
- + 5 years experiences in RA
- Fluent in English
- Strong communication skills (orally and written)
- Good in reading communication
- Critical thinking
- Attention to details
- Knowledge of principles and processes for providing customer services
- Data Management: Ability to locate, organize, store and back up files in a systematic fashion.
- Task Prioritization: Must be sensitive to time deadlines so that work is accomplished in the time frames required
- Ability to write reports, business correspondence, and procedure manuals.
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.