Drug Regulatory Affairs Coordinator
Posted on Mar 16, 2021 by RM IT Professional Resources AG
Drug Regulatory Affairs Coordinator vacancy for a globally operating Zug based company in the pharmaceutical sector.
- 3+ years' working experience plus background in Project Management, Functional Breadth, Operations Management and Execution
- Solid knowledge of global regulatory/quality requirements and training management
- Familiarity with KPIs in Safety Labelling, Routine Health Authority, Drug Shipping Processes and comparable
- Good understanding of MS Applications; Word, Excel, PowerPoint and SharePoint
- Excellent team player with the ability to be the authority figure and to work well under pressure
- Languages: English, fluent in written and spoken
- Coordinating and preparing high quality submissions of regulatory dossiers for assigned products
- Achieving the CTA/NDA submission and the approval of CTA, NDA and other related supplementary application on the targeted date
- Ensuring license renewal submission, approval and registration master file update on time as well as CMC/BPI/PSUR/RMP in line with NMPA regulation and company's internal policies
- Communicating questions and the registration status to the line manager along with tracking the registration sample, dossier and certificates
- Providing regulatory support for other functions and establishing good communication and relationship with key stake holders
- Being responsible for regulatory maintenance activities such as CMC variation, renewals and additionally assigned tasks
- Safeguarding optimal launch preparations for new products in close collaboration with the regulatory affairs manager, product management, local and global supply chain management and quality assurance
Location: Zug, Switzerland
Does this Spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
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As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
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