Role & responsibilities

- Candidate will be responsible for preparing, reviewing, and submitting regulatory dossiers including CTD/eCTD for ANDA, NDA, DMF, MA, and product registrations.

- Candidate will be responsible for handling regulatory submissions to CDSCO, USFDA, EMA, MHRA, and other global regulatory authorities.

- Candidate will be responsible for coordinating with R&D;, QA, QC, Manufacturing, and Marketing teams for regulatory requirements.

- Candidate will be responsible for preparing and submitting post-approval variations, renewals, amendments, and supplements.

- Candidate will be responsible for monitoring and ensuring compliance with current regulatory guidelines and requirements.

- Candidate will be responsible for responding to regulatory queries, deficiency letters, and agency communications.

- Candidate will be responsible for maintaining regulatory documentation,



submission records, and tracking timelines.

- Candidate will support regulatory audits and inspections and ensure timely closure of regulatory requirements.

Preferred candidate profile

- Candidate should have 510+ years of experience in Pharmaceutical Regulatory Affairs.

- Candidate should have experience in CTD/eCTD dossier preparation and regulatory submissions.

- Candidate should have exposure to domestic and international regulatory markets.

- Candidate should have good knowledge of USFDA, EMA, MHRA, CDSCO, and applicable regulatory guidelines.

- Candidate should have positive coordination, documentation, communication, and regulatory submission skills.

📌 Regulatory Executive / Manager - Pharma Co- Mumbai
🏢 HRD House
📍 Mumbai