Key Skills

- Extensive experience in regulatory filings for China, Brazil, Korea, WHO, South Africa, and other emerging markets
- Robust expertise in CMC (Chemistry, Manufacturing & Controls) documentation
- Hands-on experience in Post-Approval Change Management
- In-depth knowledge of emerging market dossier formats and regulatory compliance
- Sound understanding of evolving regulatory requirements across agencies such as ANVISA (Brazil), NMPA (China), MFDS (Korea), SAHPRA (South Africa), WHO, and other international regulatory authorities
- Strong cross-functional collaboration, stakeholder management, and communication skills

Key Responsibilities

- Lead the preparation, review, and submission of new DMFs/dossiers for emerging markets.
- Prepare and review responses to regulatory deficiencies and ensure high-quality, compliant submissions.
- Assess manufacturing change controls for regulatory impact and ensure timely implementation as per regional requirements.
- Manage lifecycle submissions,



including annual reports, supplements, variations, amendments, and post-approval changes.
- Monitor updates to pharmacopoeial monographs, communicate changes to cross-functional teams, and ensure timely implementation and dossier updates.
- Coordinate effectively with Manufacturing, Quality, R&D;, Marketing, and other cross-functional teams to obtain required documentation for regulatory submissions.
- Ensure timely submission of pre- and post-change notifications along with supporting documentation to customers.
- Collaborate with Marketing and Formulation teams to facilitate smooth and timely regulatory filings.
- Provide regulatory support during customer and agency audits and ensure ongoing regulatory compliance.
- Execute additional responsibilities as assigned by the Head of Department.

📌 Sr. Manager / AGM RAD (Hyderabad)
🏢 Apitoria Pharma
📍 Hyderabad