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Regulatory Expert (all genders)
Posted 26 May 2023
Schaffhausen, Schaffhausen - Switzerland
Req Id 264900
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
In this exciting opportunity you will support regulatory submissions of active pharmaceutical ingredients (APIs) and excipients. As a Regulatory Affairs Expert you will ensure that relevant changes to product registrations and listings are properly notified to the relevant authorities and maintained. This role is part of a global regulatory team and you will interact closely with the quality and operational units at the site. Furthermore, you will collaborate with internal experts within the business areas and across the business organisation to gather data and support efforts. Moreover, participation as the Regulatory Representative in the product development process to develop and execute regulatory strategies, assessments and plans is key, and interaction with external customers will be required.
- Bachelor or Master level of education in Pharmacy or Life Sciences with a strong emphasis in Chemistry or Biology
- Relevant industry experience and/or regulatory affairs experience related to APIs, pharmaceutical excipients and process materials
- Knowledge of US FDA and EU drug regulations, specifically for submissions in CTD format. Knowledge of regulatory landscape of other important regions, e.g., in Asia.
- Expertise in QC and QA for pharmaceutical starting materials and requirements of pharmacopeias
- Knowledge of regulations relevant to pharmaceutical starting materials, quality requirements and preferably processing of APIs and excipients in general. You should be well-versed in regulatory trends for pharmaceutical raw and starting materials.
- Proficient in MS Office Software (Word, Excel, PowerPoint, Project) and ERP Systems such as Oracle or SAP.
- Demonstrate good communication & project management skills. Work successfully within a multidisciplinary international team.
- Very good knowledge of English (written and spoken) and good knowledge of German
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!