Regulatory Executive / Manager - Pharma Co- Mumbai

HRD House; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

HRD House is seeking a Regulatory Affairs professional in Mumbai, India, to manage regulatory dossiers and submissions across multiple authorities. The role requires coordination with R&D, QA, QC, Manufacturing, and Marketing to ensure compliance and timely approvals.

The candidate will handle post-approval variations and respond to agency communications, while maintaining meticulous regulatory records and supporting audits.

Qualifications

• 510+ years of experience in Pharmaceutical Regulatory Affairs.
• CTD/eCTD dossier preparation and regulatory submissions.
• Exposure to domestic and international regulatory markets.
• Knowledge of USFDA, EMA, MHRA, CDSCO guidelines.

Responsibilities

• Preparing, reviewing, and submitting regulatory dossiers (CTD/eCTD) for ANDA, NDA, DMF, MA, and product registrations.
• Submitting regulatory submissions to global authorities (CDSCO, USFDA, EMA, MHRA).
• Coordinating with R&D, QA, QC, Manufacturing, and Marketing for regulatory requirements.
• Preparing and submitting post-approval variations, renewals, amendments, and supplements.
• Monitoring compliance with current regulatory guidelines and responding to regulator queries.
• Maintaining regulatory documentation, submission records, and timelines.
• Supporting regulatory audits and inspections and ensuring timely closure of requirements.

Skills

Regulatory affairs

Job description

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 good coordination, documentation, communication, and regulatory submission skills.