agap2 is a European engineering consultancy. It was founded in 2005 and is specialized in industry. We are focusing on Pharmaceuticals, Biotechnology, Medical Devices, Energy, Transportation, Chemistry and IT sectors.
agap2 works today with more than 4500 co-workers, mainly engineers and doctors. We intervene on global projects from our European agencies: Switzerland, Germany, Belgium, Spain, France, Italy, the Netherlands, Portugal, United Kingdom and Sweden.
agap2 strives for excellence and quality at all levels, bearing a deep knowledge of each sector that we support. The recruitment of the best consultants as well as real career evolution perspectives are the key factors to our growth.
agap2 Switzerland, with 200 collaborators in our agencies in Lausanne, Basel and Zurich, is a key partner to companies such as GSK, UCB, Merck, Johnson & Johnson, Philip Morris, Roche, Novartis, Biogen ors Takeda.
agap2 is a European engineering consultancy. It was founded in 2005 and is specialized in industry. We are focusing on Pharmaceuticals, Biotechnology, Medical Devices, Energy, Transportation, Chemistry and IT sectors.
agap2 works today with more than 4500 co-workers, mainly engineers and doctors. We intervene on global projects from our European agencies: Switzerland, Germany, Belgium, Spain, France, Italy, the Netherlands, Portugal, United Kingdom and Sweden.
agap2 strives for excellence and quality at all levels, bearing a deep knowledge of each sector that we support. The recruitment of the best consultants as well as real career evolution perspectives are the key factors to our growth.
agap2 Switzerland, with 200 collaborators in our agencies in Lausanne, Basel and Zurich, is a key partner to companies such as GSK, UCB, Merck, Johnson & Johnson, Philip Morris, Roche, Novartis, Biogen ors Takeda.
YOUR TASKS :
- Coordination, preparation, screening and timely creation of CMC registration documentation (especially module 3) for submission and variation dossiers of national and international projects
- Answering to deficiency letters of regulatory authorities
- Assuring compliance with regulatory requirements and consistence with external and internal regulatory specifications and quality standards
- Development of regulatory strategy from the RegCMC perspective
- Acting as a contact person for RegCMC expertise in cross-functional teams
- Development and preservation of relationships with regulatory authorities regarding pre-submission strategies, possible registration paths, compliance test requirements, as well as clarification and prosecution of submitted dossiers
- Preparing and conducting trainings for colleagues with regard to current regulatory standards and best practice
YOUR PROFILE :
- Master diploma, PhD or equivalent in pharmacy, biology, biochemistry or related scientific field
- Completed first experience in pharma Regulatory CMC for biological products
- Experience with products / substances in development is a certain advantage
- Fluent in French and English mandatory
Please send your application with an updated CV and a motivational letter to recruitment.lausanne@agap2.ch