Sunday, July 26, 2020

Regulatory Affairs Officer/Executive in USFDA API Manufacturer Turbhe

Regulatory Affairs Officer/Executive in USFDA API Manufacturer Turbhe.

HEMMO PHARMACEUTICALS PVT. LTD. 

Experience: 4 to 7 yrs

Job Description
                     
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

Education:

(UG - B.Sc - Chemistry) AND (PG- M.Sc - Chemistry) AND (Doctorate-Not Required)

Contact Details

Recruiter Name:

Mrs.Sneha Chavan/ 9321622308


Contact Company:

HEMMO PHARMA
Address:

C-43, M.I.D.C., T.T.C. Industrial Area,,Turbhe, Off Thane Belapur Road,, THANE, Maharashtra - 400601, India

Email Address:

hr@hemmopharma.com

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