Regulatory Affairs Officer

7 days ago

Sola Ahmedabad Gujarat, India West Coast Pharmaceutical Full time

**Job Responsibility**:

- Prepare, compile, and review CTD/eCTD dossiers for submissions (e.g., ANDA /NDA/MAA).
- Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.
- Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.
- Ensure completeness and technical accuracy of eCTD sequences.
- Troubleshoot validation issues before final submission.
- Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes).
- Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II).
- Collaborate with internal departments to gather data and draft scientifically sound responses.
- Stay updated with changes in FDA, EMA, and ICH guidelines.
- Maintain regulatory databases, submission trackers, and approval records.
- Participate in audits and support regulatory inspections.

**Job Types**: Full-time, Fresher

Pay: ₹10,000.00 - ₹50,000.00 per month

Schedule:

- Day shift

Work Location: In person

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