Senior Executive-Regulatory Affairs-ROW(Mumbai)

We are looking for an experienced Senior Executive Regulatory Affairs with hands-on experience in ROW market registrations for injectable pharmaceutical products.

Key Responsibilities

• Preparation, compilation, review and submission of regulatory dossiers for injectable products for ROW markets.
• Preparation and review of dossiers in CTD/eCTD and country-specific formats.
• Handle new product registrations, renewals, variations and post-approval changes.
• Review technical documents including MFR/BMR, specifications, analytical methods, stability data, process validation, manufacturing information and product development documents from a regulatory perspective.
• Coordinate preparation and submission of Module 1, Module 2, Module 3 and other applicable dossier documentation.
• Handle regulatory authority queries/deficiencies and coordinate with concerned departments for timely responses.
• Review artworks, labels, package inserts, SmPC/PIL and prescribing information as per country-specific regulatory requirements.
• Coordinate with QA, QC, Production, R&D, Packaging, Business Development and other departments for dossier documentation and regulatory submissions.
• Maintain country-wise registration status, submission trackers, deficiency trackers, approval records and regulatory databases.
• Review and coordinate documentation related to manufacturing licences, GMP certificates, CPP, FSC and other legalised/apostilled documents required for international registrations.
• Monitor changes in regulatory requirements of assigned ROW countries and ensure timely compliance.
• Support regulatory requirements for injectable products, including sterile manufacturing-related documentation.
• Ensure timely submissions, responses and approvals in coordination with internal teams and overseas business partners/agents.

Candidate Profile

• B.Pharm / M.Pharm / M.Sc. or relevant qualification.
• 4–7 years of Regulatory Affairs experience, with significant exposure to Injectables and ROW markets.
• Strong knowledge of CTD/eCTD dossier compilation and Module 3 documentation.
• Experience in handling new registrations, renewals, variations and regulatory queries.
• Good understanding of sterile/injectable manufacturing and regulatory requirements.
• Strong documentation, coordination and communication skills.

Candidates having hands-on experience in ROW dossier submissions for injectable products will be preferred.

Interested candidates may share their updated CV mentioning Current CTC, Expected CTC, Notice Period and ROW markets handled. send resume to [email removed],[email removed]