Cadila Pharma Hiring For Regulatory Affairs Department

Cadila Pharma Hiring For Regulatory Affairs Department

Urgent opening for a large pharma company for the Regulatory Affairs (API) department. 

Designation - Executive/ Sr. Executive

Qualification - M.sc (Chemistry)

Experience - 3 to 5 Years

Major Roles & Responsibilities: 

· Preparation of drug master file and its submission to various regulatory authorities.

· Preparation of query response of drug substances for various regulated and less regulated markets and customers.

· Preparation of applicant part and closed part for various authorities and customers.

· Preparation of annual updates, biannual updates, and Amendments of Drug Master Files of various countries.

· Preparation of CEP LOAs and declarations of various customers and authorities.

· To review specification, impurity profile and characterization report, Force degradation report, and Method Validation report, of drug substance for submission of DMF.

· Preparation of CTD format Drug Master files for various regulated and non-regulated markets.

· Submission of drug master files and updates to the US via ESG and Europe via CESP and Korean authorities.

· To collect and evaluate scientific data for assessment in search of discrepancies or compromises in quality to prepare submissions.

· To review and fill out a questionnaire for Nitrosamine Impurities provided by the vendor.



Please reach out on the below details;

Email ID - rima.barot@cadilapharma.com