By SWARNALATHA B 
We’re Hiring | Senior Manager / Assistant General Manager – Regulatory Affairs (API)
Apitoria R&D, a 100% subsidiary of Aurobindo Pharma Ltd., is looking for an experienced Regulatory Affairs (API) professional to join our team at Pashamylaram, Hyderabad.
🔹 Qualification: M.Sc. (Chemistry) / M. Pharma
🔹 Experience: 12–15 Years
Skill Set:
Regulatory filings for China, Brazil, Korea, WHO, South Africa & other emerging markets
CMC documentation and dossier preparation
Post-Approval Change Management
Emerging market regulatory compliance and lifecycle management
Cross-functional collaboration and stakeholder management
🔹 Job Description:
◾ 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 pharmacopeial 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 per the organizational requirement.
If you’re passionate about driving global regulatory excellence and are looking for an exciting career opportunity with relevant experience, you may apply by scanning the QR code given below. 👇
