Job Description
Key Responsibilities:
- Prepare and submit regulatory filings to the US-FDA.
- Provide technical guidance on authoring templates and ensure compliance with electronic regulatory submissions.
- Collaborate with Regulatory and IT teams to maintain critical regulatory documentation.
- Coordinate with the CMC team to prioritize and schedule submissions.
- Collect finalized documents related to ANDA/DMF submissions.
- Perform document formatting, pre-publishing, submission compilation, validation, and submission via ESG (Electronic Submission Gateway).
Required Skills & Experience:
- 1-5 years of experience in Regulatory Operations.
- Proficiency in eCTD compilation software (e.g., Veeva RIMS, ISI Toolbox, Lorenz Validator).
- Strong understanding of US-FDA submission guidelines.
- Excellent coordination and communication skills.
Educational Qualification:
- Minimum B.Pharm degree required.
