Regulatory Affairs Officer/Execitive

RBM Placement

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