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Regulatory Affairs Associate I
ConfidentialBengaluru / Bangalore9 days ago
Job descriptionCompile variation packages for products in the portfolio in collaboration with relevant stakeholders. Manage regulatory databases and Trackwise system efficiently. Academic degree with a chemical / pharmaceutical background. 2-5 years of experience in CMC Regulatory Affairs, focusing mainly on Europe and International Markets. Proficient in registration procedures and pharmaceutical regulations. Familiarity with Document Management Systems. Strong prioritization skills and ability to adhere to timelines. Capable of working independently with moderate guidance. Problem-solving abilities and implementation of process improvements. Team player mentality.
Assessment of Change Controls :
- Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.
Variations Compilation :
Regulatory Database Management :
Experience and Qualifications : Qualifications :
Experience :
Reporting Structure : Reports to Senior Manager CMC Regulatory Affairs
Skills Required
Regulatory Compliance, Clinical Trials, Risk Management
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Associate Regulatory • Bengaluru / Bangalore
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