SummaryAssociate is responsible for the Regulatory submissions to US-FDA
Provides technical guidance, related to use of authoring templates and impact to electronic regulatory submissions, to subject matter experts during document authoring- Supporting the Regulatory Operations by working closely with team members across the Regulatory and IT functions to ensure that critical regulatory documentation is properly created and maintained.
Coordinate with CMC team to prioritize to schedule submissions. Coordinate with CMC team to collect the finalized documents relevant to ANDA/DMF.
Perform document formatting and pre-publishing, submission compilation, validation, and submission through ESG.
Additional
Experience in handling eCTD compilation software, VEEVA- RIMS, ISItool box, Lorrenze validator, etc., Minimum Experience 1-5 years in Regulatory operations.