1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
6 Opening(s)
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
DMF API Submission experience is must
Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
Preparation of Applicant part of DMF for Brazil, US, and ROW market.
Preparation of all administrative statements for respective authority requirements.
Drafting of regulatory response for ...
1 Opening(s)
3.0 Year(s) To 10.0 Year(s)
3.00 LPA TO 5.00 LPA
Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's.
Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & ...
2 Opening(s)
2.0 Year(s) To 7.0 Year(s)
2.00 LPA TO 5.00 LPA
Key Responsibilities
Process Development:
Design and execute multi-step organic synthesis experiments to develop new and innovative routes for API synthesis.
Conduct literature searches and patent reviews to identify non-infringing and commercially viable synthesis routes.
Optimize reaction parameters such as temperature, pressure, time, and solvent to improve yield, purity, and reduce costs.
Technology Transfer:
Prepare and document ...
1 Opening(s)
2.0 Year(s) To 3.0 Year(s)
0.50 LPA TO 5.00 LPA
Job Description – Key Responsibilities:
✅ Support formulation development activities for regulated and semi-regulated markets, ensuring alignment with project timelines and quality standards
✅ Conduct pre-formulation, API-excipient compatibility studies, and stability testing to evaluate formulation feasibility
✅ Assist in scale-up and technology transfer from R&D to manufacturing, ensuring smooth transition and documentation
✅ Prepare ...
5 Opening(s)
3.0 Year(s) To 5.0 Year(s)
0.50 LPA TO 6.00 LPA
Job Summary: We are looking for a highly motivated and detail-oriented R&D Research Associate to join our API development team. The ideal candidate will be responsible for supporting the design, development, and optimization of synthetic processes for Active Pharmaceutical Ingredients (APIs), ensuring scalability, regulatory compliance, and quality standards. This role ...