2 - 7 years
3 - 7 Lacs
Posted:1 month ago|
Platform:
Work from Office
Full Time
International Product filing Registrations and life-cycle management
Expertise in Regulatory Norms for regulated markets / emerging market.dossiers, renewal & variation applications for various markets based on CTD, ACTD and/or other region-specific requirements.Respond to queries raised by regulatory agencies and/or local partners of the above regions.Review and give regulatory feedback on technical documents like process validation, AMV, Stability and composition, labeling, batch records, specification or test methods, etc. Ensure accuracy and compliance of documentation.Artwork recommendations and approvals as per regulatory provisions.Well-versed in ICH guidelines, maintain awareness of legislation and current developments in regulatory affairsCross-Functional Team WorkRepresent regulatory affairs at cross functional meetings and coordinate with R&D, Production, Plant QA/QC and Marketing to efficiently and successfully complete regulatory activitiesSupport plant teams in regulatory audits, liaison with domestic & export regulatory authority.Assess and approve change controls and update files accordingly .
Interested candidates share their CV to
narasimharaju.manthena@msnlabs.com
MSN Group
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