Position: Assistant Manager – Regulatory Affairs

Department: Regulatory Affairs
Location: Pune, India
Experience: 7–10 Years
Qualification: B. Pharm / M. Pharm
Work Type: Full time / In office
Reporting To: Manager / Head – Regulatory Affairs
Preferred: Male/ Female candidate

About the Role

We are seeking a proactive, detail-oriented Assistant Manager – Regulatory Affairs with robust experience in Middle East & North Africa (MENA), Africa & LATAM markets. The role involves regulatory submissions, dossier preparation, lifecycle management, and ensuring compliance for global registration across ROW markets, leading to timely product approvals.

Key Responsibilities
Regulatory Strategy, Dossier Preparation & Submissions
Lead and manage preparation, review, and submission of eCTD/CTD/ACTD dossiers for product registrations, renewals, and variations across MENA, Africa & LATAM regions.
Develop and implement market-specific regulatory strategies aligned with business objectives.




Ensure dossiers meet country-specific formatting including Module 1 (Administrative/Country Specific requirements).
Coordinate with internal teams to ensure timely, accurate submissions and handle deficiency letters/queries from regulatory agencies.
Regulatory Compliance, Documentation & Record Management
Review technical documentation, CMC data, analytical methods, and stability reports for compliance.
Collaborate with R&D;, QA, QC, Production, Marketing, BD, and Sourcing to gather and validate submission data.
Maintain regulatory trackers, submission logs, and correspondence databases.
Support audits, ensuring systems and documentation are audit-ready and compliant.
Labeling, Artwork & Post-Approval Compliance
Review and approve packaging, labeling, and promotional materials for compliance in MENA, Africa & LATAM markets.
Coordinate with artwork and marketing teams to incorporate approved regulatory text.
Manage post-approval changes, renewals, and labeling upda

📌 Assistant Manager Baner (India)
🏢 RTM Healthcare
📍 India