Regulatory Affairs Professional (food supplements industry) (m/f/d)

Lonza
Colmar
EUR 40 000 - 60 000
Description du poste

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 a 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 the 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 in 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, bioengineering, biotechnology, food technology
  • 2/3 years experience 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 detail
  • 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
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