Regulatory Affairs Assistant Manager

Key Responsibilities:

1. Regulatory Strategy, Dossier Preparation & Submissions

• Lead and manage the preparation, review, and submission of eCTD/CTD/ACTD dossiers for product registrations, renewals, and variations across semi-regulated and unregulated markets.
• Develop and implement region-specific regulatory strategies aligned with corporate objectives.
• Ensure dossiers are formatted per country-specific requirements, including Module 1 (Administrative/Country Specific), and assist the global regulatory team with regional variations.
• Coordinate with internal teams to ensure timely, accurate, and compliant submissions, and handle queries or deficiency letters from regulatory authorities.

2. Regulatory Compliance, Documentation & Record Management

• Review technical documentation, CMC data, and stability reports for completeness and compliance.
• Collaborate with R&D, QA, QC, Production, Marketing, BD, and Sourcing teams to gather and validate submission data.
• Maintain and update regulatory databases, trackers, and correspondence logs.
• Support audits and inspections by ensuring documentation systems are compliant and audit-ready.

3. Labeling, Artwork & Post-Approval Compliance

• Review product labeling, packaging, and promotional materials for regulatory compliance.

4. Regulatory Intelligence & Market Monitoring

• Monitor and interpret regulatory changes across ROW and emerging markets.
• Communicate significant updates and market trends to internal stakeholders.
• Support implementation of new or revised regulatory guidelines into templates and documentation processes.

5. Communication, Stakeholder Management & Leadership Support

• Serve as a key contact for regulatory authorities, partners, and distributors, ensuring timely submissions and approvals.
• Provide status updates and reports to senior management.
• Mentor and guide junior regulatory staff, promoting best practices in dossier preparation and documentation.

Uphold global quality and compliance standards across regulatory operations.

• Coordinate with marketing and artwork teams to implement approved text and claims.
• Maintain labeling databases and manage renewals and post-approval variations.

Job Type: Full-time

Pay: ₹400,000.00 - ₹700,000.00 per year

Application Question(s):

• Do you have exposure of Middle East/ MENA Market?