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
Solid cross-functional collaboration, stakeholder management, and communication skills

Key Responsibilities
Lead the preparation, review, and submission of current 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