Regulatory Affairs Professional

France, Colmar
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 for following (non limiting) areas of interest:
  • Legislative evolutions and industry guidance in the domain of excipient, pharmaceutical and food manufacturing.
  • Overall GMP requirements.
  • Main scope is empty hard capsules and dosage from solutions.
  • Draw up documented regulatory impact assessments, translate applicable regulations or guidelines into comprehensive action plans and ensure proper implementation.
  • Create and maintain relevant documentation, registration files, working instructions and standard operating procedures as part of the quality system and regulatory requirements.
  • Actively support EMEA customers and authority requests related to regulatory requirements and standards with the aim to increase Customer Satisfaction and regulatory compliance through timely providing professional and satisfactory solutions.
  • Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives. In this context, following activities:
  • Leverage regulatory compliance as business value, actively participating with sales and marketing.
  • Prepare EMEA regulatory assessments for regionally and globally relevant regulatory topics of interest
  • Prepare business impact assessments for emerging regulatory topic
  • Maintain appropriate internal and market support tools.
  • Support collaboration with regulatory and certification bodies to ensure solutions for market requirements and to maintain required certifications.
  • Participate to relevant and value adding industry conferences as well as required external and internal regulatory expert networks or trade associations.

Key requirements:

  • Master degree or similar in pharmacy, chemistry, bio engineering, biotechnology, food technology
  • 2/3 years experiences in RA
  • Fluent in English and French
  • Strong communication skills (orally and written)
  • Good in reading communication

  • Critical thinking

  • Attention to details

  • Knowledge of principles and processes for providing customer services

  • Data Management: Ability to locate, organize, store and back up files in a systematic fashion.

  • Task Prioritization: Must be sensitive to time deadlines so that work is accomplished in the timeframes required

  • 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.

Reference: R55624