
Regulatory Affairs Executive
5 days ago
Bajaj Healthcare Ltd has opening for below profile.
**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.
Plant visit w.r.t. documents checking & different Agenda.
**Salary**: ₹25,000.00 - ₹35,000.00 per month
**Benefits**:
- Health insurance
Schedule:
- Morning shift
Ability to commute/relocate:
- Thane - 400606, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 4 years (preferred)
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