Regulatory Affairs Manager

Greetings!

Job Description: Regulatory Affairs-Deputy Manager

Experinece: 5+ years

Location: Nariman Point

Position Summary

The Regulatory Affairs Officer will be responsible for managing regulatory submissions, product registrations, and post-approval activities across South Asia and Southeast Asia. The role will support the registration and maintenance of pharmaceutical products, including drugs, biologicals, injectables, and oral dosage forms, while coordinating with health authorities, local agents, distributors, regulatory consultants, manufacturing sites, and internal cross-functional teams.

The position will ensure regulatory submissions are accurate, compliant, and completed within agreed timelines to support successful product launches and continued market authorization.

Key Responsibilities

• Prepare, compile, review, and submit new product registration dossiers in CTD/ACTD formats to health authorities across assigned South Asian and Southeast Asian markets.
• Manage the complete product registration lifecycle, including:
• New product registrations
• Renewals
• Variations
• Licence amendments
• Post-approval changes
• Coordinate with local agents, distributors, and regulatory consultants to manage submissions, respond to regulatory queries, and address deficiency letters.
• Prepare and review technical and regulatory documentation, including CoPP, GMP certificates, stability data, CMC documentation, product information, and labelling materials.
• Coordinate with manufacturing, Quality Assurance, and other relevant departments to obtain GMP certificates, batch documentation, manufacturing information, and other submission requirements.
• Review product labels, artwork, packaging materials, and product information to ensure compliance with applicable local regulatory requirements.
• Monitor regulatory guidelines and legislative changes across assigned markets and assess their impact on existing registrations and upcoming submissions.
• Maintain accurate regulatory submission trackers, registration databases, and status reports for all assigned markets.
• Monitor submission and approval timelines, identify potential delays or regulatory risks, and escalate issues to the Regulatory Manager and relevant cross-functional teams.
• Maintain regulatory files, submission documents, correspondence, approvals, certificates, and other records in accordance with company SOPs and document-control requirements.
• Support regulatory due diligence, product evaluation, regulatory strategy, and new product launch activities.
• Provide regulatory input for portfolio expansion and market-entry strategies across assigned territories.
• Maintain effective communication with health authorities, distributors, agents, consultants, manufacturing sites, and internal stakeholders.
• Ensure all regulatory activities are conducted in accordance with applicable regulations, company policies, SOPs, and quality standards.