Regulatory Affairs Associate I
Navi Mumbai, India, 400706
Who we are
The opportunity
Provision of Global metrics and reports to support the business
Support GRA Compliance function
How you’ll spend your day
- Work with other members of staff for reporting EU Gx & Specialties metrics.
- Responsible for Metrics and Reporting mainly for EU, but ad hoc Globally and for supporting GRA Compliance
- Provide ad hoc global or regional reports, as required
- GRIDS data entry
- Retrieval and analysis of data from GRIDS
- Retrieval and analysis of data from Teva RA systems
- Assist with managing GRA’s procedures and learning systems for SOPs & Work Instructions, including processing through established DMS and LMS and monitoring of periodic reviews.
- The candidate will be expected to work within GRA, liaising with other business units (eg R&D, portfolio, RA etc) to ensure that all data is compliant.
- They need to be familiar with the IT systems the company uses in order to retrieve the data efficiently and accurately.
Your experience and qualifications
- Required: Bachelor’s or Master’s degree in Life Sciences or Information Technology.
- Preferred: MS in scientific or information technology discipline.
- Required: 1-3 years (Preferred experience in regulatory operations/affairs/Pharmaceuticals/biotechnology/ medical device industry).
- Significant experience in data management and handling large amounts of data
- Significant experience in use of databases and retrieving information
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