Regulatory Affairs Professional

Today Lonza is a global leader in life sciences. 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.

Lonza’s Capsules & Health Ingredients business is the trusted partner for innovative products, including capsules and health ingredients, customization services and end-to-end dosage form solutions for pharmaceutical and nutraceutical companies.

Colmar, France | Lonza is currently looking for regulatory affairs specialist to anticipate, capture, assess regulatory requirements and implement solutions in the healthcare industry (excipient, pharmaceutical and food manufacturing), where applicable, with the aim to ensure continued compliance and to sustain market recognition as a compliant business partner in a regulated environment.

**Key responsibilities**:

- Anticipate and capture regulatory evolutions relevant to empty capsules and food supplements manufacturing and sale for France and the EMEA (Europe, Middle East & Africa) region
- Follow-up on implementation of regulatory evolutions and guidelines in the Colmar, France manufacturing site
- Create and maintain relevant product documentation, registration files, working instructions and standard operating procedures
- Actively support customers in EMEA region and local authority requests related to regulatory requirements and standards
- Support internal teams (e.g. R&D, marketing, project management, QA etc.) on projects related to market growth and innovation initiatives
- Assess new ingredients for compliance with requirements in the target region and for suitability of use
- Support collaboration with regulatory and certification bodies to ensure solutions for market requirements and to maintain required certifications
- Participate to relevant industry conferences and trade associations.
- Participate in creating visibility to business around regulatory activities
- Support compliance reviews of marketing and communication materials

**Key requirements**:

- Master degree or similar in pharmacy, chemistry, bio engineering, biotechnology, food technology
- 2/3 years experiences in RA within the food (supplements) industry
- Knowledge of GMP requirements
- Fluent in English and French
- Strong communication skills (orally, written and reading)
- Critical thinking and attention to details
- Data Management: Ability to locate, organize, store and back up files in a systematic fashion
- Priority setting: ability to prioritize work and work along deadlines
- Ability to write reports, business correspondence, and procedure manuals

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.