Regulatory Affairs Executive - Bommasandra, Bengaluru, Karnataka, India - Arcos Group of Companies
Description
Roles and Responsibilities:
- Asking for necessary technical inputs from various departments in the Factories and doing its assessment.
- To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head Regulatory
- Compilation, review and submission of DMF (Drug master file) to Regulatory & ROW markets, US, Europe as per the given guidelines.
- To keep DMF files active as per the agency requirements.
- Revision/Renewal of CEP.
- Compilation & submission of Applicants part DMF (Drug master file) & QOS for customers.
- To get the necessary information from QA, QC for compilation and onward submission to regulatory authorities and customers as response to their queries
- To evaluate the technical agreements /CDA to be signed with the customers as on basis.
- Review of vendor questionnaire within the required timeframe along with supporting documents to customers and maintaining the record for the same.
- Preparation of LOAs.
Job Type:
Regular / Permanent
Salary:
From ₹35,000.00 per month
Benefits:
- Health insurance
- Internet reimbursement
- Provident Fund
Schedule:
- Morning shift
Supplemental pay types:
- Yearly bonus
More jobs from Arcos Group of Companies
-
Recruiter
Sirani, India - 1 week ago
-
Real Estate Salesperson
Gurgaon, India - 2 weeks ago
-
Housekeeping Supervisor
Noida, India - 3 weeks ago
-
Logistics Administrator
Guwahati, India - 2 weeks ago
-
Operation Executive
Jaipur, India - 3 weeks ago
-
Operations Executive
Changsari, India - 1 week ago