Apitoria Research Centre, a wholly-owned subsidiary of Aurobindo Pharma, is actively seeking a talented and experienced professional to join its Regulatory Affairs department in Hyderabad. This challenging and rewarding role is for a Deputy Manager or Manager specializing in Active Pharmaceutical Ingredient (API) Regulatory Affairs, with a specific focus on the dynamic China market.
Prospective candidates should possess a strong academic background, holding an MSc in Chemistry or an M. Pharm degree. A robust professional history is also essential, with 7 to 10 years of dedicated experience in API Regulatory Affairs.
The ideal candidate will demonstrate a comprehensive understanding and practical expertise in China’s regulatory environment. Key responsibilities for this position include:
- Drug Master File (DMF) Management for China: Expertly compiling, reviewing, and submitting new DMFs in strict accordance with the guidelines set by the China Agency (NMPA).
- Lifecycle Management: Overseeing the complete lifecycle of DMFs, which involves preparing and submitting all necessary amendments, renewals, and annual reports to the NMPA. This also includes diligently addressing agency responses and handling deficiencies received from the CDE.
- Regulatory Compliance and Strategy: Conducting thorough gap assessments and developing effective control strategies crucial for the preparation of high-quality DMFs, thereby minimizing potential queries and ensuring full regulatory adherence.
- Cross-functional Collaboration: Facilitating seamless coordination with the China office and various internal teams, including Quality Assurance, Quality Control, Research & Development, Analytical R&D, and Production, for the efficient collection and review of required documentation.
- Documentation and Tracking: Establishing and maintaining an organized and comprehensive tracking system for all submitted regulatory documents and their corresponding responses.
This role demands a meticulous and proactive professional with a deep commitment to ensuring timely and compliant regulatory submissions within the Chinese pharmaceutical landscape.
Interested candidates who meet the specified qualifications and experience criteria are invited to explore this opportunity further. For detailed application instructions, please refer to the complete job advertisement, which typically includes a visual recruitment poster.
