Regulatory Affairs Officer

West Coast Pharmaceutical

0 years

1 - 6 Lacs

Sola, Ahmedabad, Gujarat

Posted:1 day ago| Platform: SimplyHired logo

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Skills Required

In-person

Work Mode

On-site

Job Type

Full Time

Job Description

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.
Submit applications to US FDA, EMA, and other authorities in compliance with regional requirements.
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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