Lonza

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.

This role is responsible for regulatory compliance of Lonza’s CHI Capsugel®

empty capsule portfolio in Europe, Middle East and Northern Africa (EMEA)

With intended use in pharmaceutical products and food supplements.

The role also supports interaction with the local Belgian Food Safety

Authorities for the empty capsule manufacturing site in Bornem, Belgium

Including facility registration aspects and import/export certification.

In addition, the role is the main point of contact for regulatory support for

customers and internal sales/customer service/QA teams, and leverage

regulatory compliance and demonstrates regulatory compliance as a business

value.

Key Responsibilities:

• Capture regulatory evolution, 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
• Support internal EMEA partners (sales / marketing / commercial / logistics) with any regulatory changes, by providing training sessions on any (regulatory) topic and engaging in discussions to ensure appropriate implementation in case of regulatory impact
• Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance
• Support marketing, R&D, Lonza BU, and working groups from customers in ad hoc projects, in relation to market growth and innovation initiatives by preparing EMEA regulatory assessments for relevant regulatory topics of interest. Where vital, engage in discussions with the appropriate trade organizations to support innovation
• Support the logistics team by determining the correct export / import certificate to be used and by reviewing and signing off on export certificates issued in the context of shipping goods from EMEA to countries outside the EU. Where needed, liaise with local and foreign Authorities to come to an agreement
• Participate to relevant and value adding industry conferences as well as required external and internal regulatory expert networks or trade associations

Key requirements:

• Bachelors or Master’s degree in life sciences area or equivalent experience in a highly regulated field
• Previous experience with the GMP environment
• Proficiency in English

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.