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Teva Regulatory Affairs Associate III- RA CMC Lifecycle EMSO APAC India, Maharashtra, Navi Mumbai 338810338
09.07.2025
How you’ll spend your day
- Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market.
- Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders.
- Responsible to keep trackers and database up to date.
- Briefing the regulatory status in different forums associated with cross functional teams.
- Experienced in managing software related to Regulatory Affairs and QMS.
Your experience and qualifications
- Academic Degree/PG and thinking level with a chemical/pharmaceutical background.
- 6+ years of experience in CMC Regulatory Affairs; Europe and International Market preferred.
- Knowledge on EU registration procedures and pharmaceutical regulations.
- Good communication skills (written and oral).
- Interest and capability to work with different software, including Document Management Systems.
- Accurate, able to prioritize and work according to agreed timelines.
- Working independently with a moderate level of guidance and direction.
- Solve complex problems using existing solutions and support.
- Identify & implement process improvements. Team player
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