Manager, Regulatory Affairs
il y a 4 semaines
Belgium, VerviersToday, 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.
We are currently looking for a Manager, regulatory affairs to join our site in Verviers, Belgium. He/She will be part of the regulatory affairs team that supports the Bioscience business unit, sites and project teams.
The key areas of accountability for the role are:
- Provide regulatory support for the range of products Lonza provides to Bioscience customers.
- Prepare regulatory support documentation.
- 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.
- Support the site’s and customers’ regulatory affairs activities in Verviers, Belgium.
- Work collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work
- 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 DEA records and filings.
- Submit and track agency requests including lot release and annual reports.
- Prepare monthly management reports, including budget reporting.
- 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
- Interact with clients and potential clients to develop regulatory strategies and assist in writing regulatory submissions. Provide benefit/risk analysis for suggested strategies.
- Use available systems and tools to coordinate and track regulatory activities.
- Support site-specific regulatory documents and activities.
- Maintain schedule of filings required and recommended by FDA; monitor timelines and status for filings; complete routine filings in a timely manner.
- Interpret and evaluate regulatory data to prepare documents and submissions, as appropriate.
- Anticipate, evaluate and implement trends and innovations in the Regulatory arena.
- Perform other duties as assigned.
**Education**:
Bachelor degree in Biological sciences, chemistry, biochemistry or equivalent education with at least 5 years of related regulatory experience.
English is required
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: R48715**:
-
Associate Director Regulatory Affairs
il y a 4 semaines
Verviers, Belgique Lonza Temps pleinBelgium, VerviersToday, 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...
-
QA Compliance Manager
il y a 1 semaine
Verviers, Belgique Lonza Temps pleinBelgium, VerviersToday, 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...
-
QA Qualification Manager
il y a 3 semaines
Verviers, Belgique Lonza Temps pleinBelgium, VerviersToday, 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...
-
EHS Manager
il y a 2 semaines
Verviers, Belgique Lonza Temps pleinBelgium, VerviersToday, 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...
-
Production Manager
il y a 3 semaines
Verviers, Belgique Lonza Temps pleinBelgium, Verviers 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,...
-
Site IT Lead Bioscience Emea
il y a 3 semaines
Verviers, Belgique Lonza Temps pleinBelgium, VerviersToday, 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...