Regulatory Affairs

7 days ago

Thane, India Bajaj Healthcare Full time

**Department**: Regulatory Affairs

**Designation**: Executive

**Education / Qualification**: B. Pharm

**Experience**: 3 to 5 year

**Salary**: As per company Standards

**Responsibilities**:

- Data compilation, Preparation of DCP, EDMF, CEP, and Drug Master File (DMF)/Formulation Dossier related to other countries as per marketing department requirement and handling lifecycle Management.
- Preparation of Insert as per requirement.
- Preparation of DMF Amendment, Revision report, Annual update report of the Drug master file with Regulatory Agencies [Europe, EDQM, Korea and ROW] for the regularization of Changes.
- Making responses to Health Authorities [EDQM, DCP (RMS & CMS)] and Customer queries.
- Drafting Letter of access to existing Drug Master Files and declarations/notifications for regulatory submissions and customers & Marketing department.
- Review of Analytical method validation, Process Validation, Checking BMR documents for EU DMF filings.
- Drafting and submission of Technical Information packages of New Active Pharmaceutical Ingredients for customers.
- Extracting information required for submissions from various departments (R&D, QC, QA & Production) within the organization.
- Checking of Change controls.
- Necessary communication and assessment of outsourced intermediates/Starting materials of APls.
- Regular updation of Regulatory Guidelines.
- Timely submission of DMFs as per the monthly schedule.
- Involvement of in group discussion of New projects with R&D, Marketing.

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