Regulatory Affairs/ Executive

2 weeks ago

Thane, India Bajaj Healthcare Full time

We appreciate and welcome your interest in working with Bajaj Healthcare Ltd. Bajaj Healthcare is a pharmaceutical company that develops, manufacturers and market safe, innovative and cost-effective generic pharmaceuticals that help improve patient’s quality of life. We are committed to hiring talented people and nurture them professionally. Our multi-dimensional work environment offers high growth opportunities through challenging roles with clear responsibilities and the opportunity to work on a variety of assignments. At Bajaj Healthcare, our employees are provided with opportunities to enhance their technical and soft skills through continuous training and development programmes.

At Bajaj Healthcare we strive to keep everyone connected with work, new initiatives and with the organization in a productive manner to ensure the work-life balance and effective utilization towards the attainment of individual, group, and organizational goals. The most differentiating factors leading to progress and morale boost is that we work as a team with the transparency to make the goals realistic & achievable.

We offer a wide variety of interesting employment opportunities and are continually looking for key external talent to complement our existing workforce and enhance our organizational strength, adding the diversity required to continue along our successful path.

**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.

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