Regulatory Affairs Associate

Belgium, Bornem

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.

To strengthen our Regulatory Affairs team, we are currently looking for a Regulatory Affairs Associate. You will be responsible for ensuring regulatory compliance of the Lonza Belgium site and its product portfolio by capturing and assessing applicable regulatory requirements and ensure implementation of relevant regulatory changes. As well as ensuring excellent customer experience by providing regulatory support to external and internal customers (sales / customer service / R&D / marketing / QA / logistics), and leverage regulatory compliance as business value.

Key responsibilities:

  • Capture regulatory evolutions, documented via a pragmatic impact assessments and centralized in an overview database.
  • Translate applicable regulations or guidelines into comprehensive action plans and ensure proper implementation.
  • Maintain relevant documentation as part of the quality system and regulatory requirements.
  • Assess local change requests for regulatory impact and follow-up on related regulatory action items.
  • Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance.
  • Timely providing professional and satisfactory solutions to any customer/authority request related to quality standards and regulations.
  • Supporting partnership programs and agreements with strategic and business relevant customers
  • Support internal customers like logistics, marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing EMEA regulatory assessments for  relevant regulatory topics of interest.
  • Support collaboration with regulatory and certification bodies to ensure solutions for market requirements and to maintain required certifications.

Key requirements:

  • Master’s degree in pharmacy, bioengineering, biotechnology or any relevant field
  • A first experience in regulatory affairs or in quality assurance in the pharmaceutical or the food industry
  • Fluent in Dutch and in English.
  • You are a passionate about regulatory affairs, enjoy cross-functional teamwork and have excellent communication skills.

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.

Reference: R35216