Regulatory Affairs Officer/Executive in USFDA API Manufacturer Turbhe.
HEMMO PHARMACEUTICALS PVT. LTD.
Experience: 4 to 7 yrs
1. Compilation and Filing of DMF in eCTD format for US, Europe and other countries as per requirement.
2. Follow up and compilation of responses to Queries from Regulatory Agencies.
3. Proficient Knowledge of ICH Guidelines.
4.Candidate must have good drafting Skills in Framing the responses.
5. Reviewing documents like stability analytical Method Validation, Process Validation, Specification, Method of Analysis.
6. Compilation of QC Related data while preparing the Drug Master File.
7.Familiar with preparing SOPs related to Regulatory department.
Desired Candidate Profile
(UG - B.Sc - Chemistry) AND (PG- M.Sc - Chemistry) AND (Doctorate-Not Required)
Mrs.Sneha Chavan/ 9321622308
C-43, M.I.D.C., T.T.C. Industrial Area,,Turbhe, Off Thane Belapur Road,, THANE, Maharashtra - 400601, India