Roles and Responsibilities :
Regulatory/ DMF
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 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.
Compilation & Submission of RP DMF for authorities.
Submissions of DMF Annual report to USFDA
Submissions of DMF amendments to USFDA
Reply to the queries raised by respective authorities
Customer Servicing
Responsible to address different questions and queries (technical) in the given time frame 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 the certificate of suitability for various customers
Preparation/review of different kinds of declarations as per customer requirements
Review of change control, customer notification/intimation
Keeping the track of customer notification/Intimation and response to the various queries raised by various customers & Log Maintenance
Preparation of LOAs
Experience
2 - 8 Years
No. of Openings
4
Education
Diploma, Professional Degree, Any Bachelor Degree, B.Pharma, Post Graduate Diploma, M.Pharma
Role
Regulatory Affairs Officer
Industry Type
Pharma / BioTech / Clinical Research
Gender
[ Male / Female ]
Job Country
India
Type of Job
Full Time
Work Location Type
Work from Office