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.

In our Site in Verviers, Belgium | Lonza we are looking for a Regulatory Affairs Manager who will be part of the regulatory affairs team that supports the Bioscience business unit, sites and project teams.

Key responsibilities:
• Provide regulatory support for the range of products Lonza provides to Bioscience customers.
• Monitor and maintain policies compliant with relevant regulations and guidances, coordinates investigations, prepares and submits all required reports and associated documentation, and other related functions and projects as appropriate.
•... Perform and document activities for submissions to regulatory agencies, registering products and preparing and filing the documentation for filings.
• Coordinate recalls, notifications, adverse reaction and other safety reports to FDA.
• Maintain schedule of filings required, s ubmit and track agency requests including lot release and annual reports.
• Review and approve printed material for regulated and non-regulated products. Review and disposition of non-conforming, returned and customer complaint products.
• Review, approve all documentation associated with manufacturing, validations, change control, deviations, SOP's
• Update subject matter experts and maintain transparency of information across regulatory function.

Key requirements:
• Bachelor's Degree or higher required in applicable science field or equivalent
• Regulatory Affairs Certification (RAC) Preferred
• 5+ years of experience working in Pharmaceutical/ Biotechnology or related industry preferred
• Minimum 3 years of experience preparing/authoring CMC DS sections for IMPD, IND, BLA preferred
• Project management experience
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used)
• Fluent in French and English

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
Liège Belgium

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