Associate Director Regulatory Affairs

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.

In our Site in Verviers, Belgium | Lonza we are looking for an Associate Director Regulatory Affairs who will serve Lonza’s Bioscience business unit activities within Europe by providing support such as preparation and maintenance of Lonza regulatory submissions, response to customer inquiries and requests for regulatory assistance, and support of day to day activities occurring at the Verviers, Belgium and Cologne, Germany sites manufacturing bioprocessing solutions and non-viral gene transfer products. Ad hoc support for Bioscience products may also be provided to customers and Lonza facilities in other jurisdictions such as Asia Pacific.

**Key responsibilities**:

- Prepares and maintains Lonza regulatory submissions such as US FDA and PMDA master files for bioprocessing media.
- Maintains site establishment registration and listings for products regulated by US FDA
- Conducts regulatory review and approval of applicable site policies and procedures, protocols, and reports
- Performs regulatory assessment, review, and approval (as needed) of site deviations, customer complaints, and change control
- Responsible for assessing the need for medical device reporting to US FDA and provides support as required to the product recall process
- Monitors and applies for site license and permits as required to support manufacturing and distribution activities
- Assists supply chain with preparation of import/export documentation for products shipped internationally
- Responsible for monitoring relevant agency guidance and legislation and providing feedback to key stakeholders, such as Quality, regarding potential impactful new guidance and/or revisions
- Reviews and approves printed material for regulated and non-regulated products.
- Provides regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues.
- Anticipates, evaluates and implements trends and innovations in the Regulatory arena.

**Key requirements**:

- Bachelor’s Degree or higher required in applicable science field or equivalent
- At least 5 years of bio-pharmaceutical industry experience of which at least 2 should include relevant regulatory affairs experience (e.g. devices)
- Expertise in the interpretation and communication of regulatory requirements for site product and process issues
- Working knowledge of EU and US regulatory requirements
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation
- Superb organizational skills and attention to detail
- Demonstrated skills managing project timelines, priorities and work under tight timelines Detail and results orientated
- Ability to review and critique complex technical documents
- Strategic approach and system oriented toward goals and objectives
- Ability to represent the company on regulatory issues both internally and externally
- Strong interpersonal skills and ability to interact positively with all functions and levels
- 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.

**Reference: R48715**: