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4.0 - 8.0 years
0 Lacs
hyderabad, telangana
On-site
As a Program Manager in the Presales department at Piramal Pharma Solutions, you will play a crucial role in leading and managing the end-to-end proposal development process for custom development and manufacturing of APIs, intermediates, RSM, KSM, and NCEs in response to RFPs/RFIs from global clients. **Key Responsibilities:** - Review and analyze client RFP/RFI requirements - Draft and manage proposals in alignment with cross-functional teams ensuring technical and commercial alignment with client needs - Prepare and finalize commercial proposals for various programs like Tech transfer, custom synthesis, route scouting, kilo-lab, and scale-up programs - Work closely with finance and operat...
Posted 1 week ago
12.0 - 16.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Maste...
Posted 1 month ago
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