Regulatory Expert
Regulatory Expert
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Salary Not Disclosed
1 Vacancy
Job Description
A career at our company is an ongoing journey of discovery: our 57000 people are shaping how the world lives works and plays through next generation advancements in healthcare life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role
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 ofa global regulatory teamand youwill 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 keyandinteraction with external customers will be required.
Your qualifications
- 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 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 wellversed 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: With us there are always opportunities to break new ground. We empower you to fulfil your ambitions and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious Apply and find more information at https://jobs.vibrantm
Employment Type
Full Time
