Regulatory Affairs Associate, Probiotics
BioGaia is a healthcare company that develops, markets and sells probiotic products with documented health benefits in a global arena. The products are primarily based on the lactic acid bacterium Lactobacillus reuteri which has probiotic, health- enhancing effects. BioGaia has 100 employees located in Stockholm, Lund, Eslöv, Raleigh – USA, Shanghai – China and Hiroshima – Japan.
The company is an expansive and rapidly growing phase and we are looking for a Regulatory Affairs Associate who can join us in our offices in Stockholm to help us to both manage our current product portfolio and support development and launch of our pipeline.
Define and compile appropriate documentation to support our partners in their registration process. Participate in implementation of suitable strategies for registration of new products. Develop and maintain current regulatory knowledge. Participate in registration and life cycle management activities as well as strategic and continuous improvement activities.
- Collaborate with and support partners in their registration process.
- Support development of efficient internal regulatory procedures and ways of working to support global product launch and commercialization.
- Maintain current regulatory knowledge within defined and relevant areas.
- Provide regulatory expertise in work tasks.
Education and experience:
- Degree in microbiology, biotechnology, biomedicine or a related field.
- At least 2 years of experience from regulatory affairs in pharmaceutical, food supplement, probiotic, food industry, medical device and/or health authority from global environment with a commercial focus.
- Experience from product development and or quality assurance is beneficial
- Knowledge of HACCP, cGMP and/or ISO 22000 compliance and regulations.
- Experience from working with a risk-based approach is appreciated.
- Fluency in Swedish and English. Other language skills are an asset.
Skills and personality:
- Working with high quality and precision
- Excellent communication skills in both writing and spoken language
- A ‘can-do’ attitude
- Creative thinking
Questions and application
Please send any questions and your application including CV and personal letter to Mats Silvander, Director Regulatory Affairs and Quality Assurance, email@example.com.
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