The GSC Submission Management department was established in 2010, with the purpose of delivering high-quality registration dossiers to our affiliates worldwide. The focus area of our department is to provide a superior service to our stakeholders consistently and add value to our submission processes in terms of standardization and efficiency.
Position:Â Associate Analyst – Regulatory Operations
- Compilation and delivery of country-specific files across IO for Renewals and Additional Manufacturing sites by preparing an operational plan and checklist of local requirements for each submission.
- Circulate the plans and requirements to RA in Affiliate for confirmation, TOC compilation according to compliance form or according to Site Transfer TOCs provided by RA CMC & Devices: search for documents in novoDOCS and populate TOC, Raise Publishing Online Form request according to submission size and publishing lead-times and QC of Published Output and Maintain the submission tracker.
Qualifications
The knowledge, skills, and experience will be required.
- Graduate or Post Graduate in Science or comparable degree in a computer-related field or equivalent professional experience
- Around 5 years of experience in the Pharmaceutical Industry in Regulatory Affairs
- Experience in compilation of Registration/Re-registration dossier in National/eCTD/NeeS and Standard format
- Experience in Document Management system
- Speaks and writes English at a professional level
- Is service minded and customer-oriented
- Demonstrates a high-quality mindset
- Structured and organized and able to maintain the overview
- Ability to work in teams
- Ability to perform in peak periods, work under tight deadlines and under a high workload
- Focuses on targets and delivers results
- Act proactively
- Works independently
- Good Analytical Skills
- Easily adaptable to the team environment
- Strong work ethics and integrity
Last Date for Application: 15th June 2020
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