1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
12.00 LPA TO 18.00 LPA
Job Description
Heading the regulatory department of the company and leading a team of executives/Senior executives/Asst.Manager.- Must be aware of the latest country specific guidelines for ROW market and capable of planning and implementing,guiding, supporting, reviewing and finally approving the dossiers and implementing the other defined activities of thedepartment.- Coordination with ...
1 Opening(s)
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the ...
1 Opening(s)
7.0 Year(s) To 8.0 Year(s)
2.40 LPA TO 3.00 LPA
1. Raw Material, Packing Material, Intermediate and Finished API analysis2. Analysis related Documentation3. Operation & Calibration of Polarimeter, FTIR, HPLC, GC4. Document preparation & management as per GLP & GDP5. Stability sample handling and analysis6. SOP preparation-revision, Analytical Method Validation and related documents preparation Should be proficient in wet chemical ...