Ra - Officer

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.

**Department**: Regulatory Affairs

**Designation**: RA - Officer

**Education / Qualification** : B. Pharm

**Experience**: 0 to 1 year

**Salary**: As per company Standards

**Responsibilities**:

- Registering our manufacturing site in Sedex platform, completing Responsible Sourcing Policy and initiating for Smeta 4 pillar Audit from 3rd party Audit Agency.
- Quality Management System Audit Preparation (ISO 9001: 2015)
- Preparing company and API (product) presentation.
- Data compilation and Preparation of Drug Master File (DMF) related to other countries as per marketing department requirement.
- Preparing Technical Packages for existing/prospective customer for initial assessment of the API.
- Making responses to 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 DMF filings.
- Drafting and submission of Technical Information packages of New Active Pharmaceutical Ingredients for customers.
- Drafting and Reviewing of Drug Master Files/Technical Package Applicants Parts of Key starting materials.
- Extracting information required from various departments (R&D, QC, QA & Production) within the organization for responding to the market complaints/ queries of customers.
- Necessary assessment of outsourced intermediates/Starting materials of APIs.
- Plant visit w.r.t. documents checking and different Agenda.
- Preparing & Reviewing regulatory documents to support ongoing regulatory requirement.
- Arranging & dispatching the samples to customers for business development.
- To share filled Vendor questionnaire and supporting attachments required for qualification and approval.
- To carry out Vendor assessment for the Key starting materials; Raw material, solvents, reagents which are procured on Domestic level as well as which are Imported.
- To collect samples from respective manufacturing unit and arranging analysis of the same in outside laboratories for various test parameters.
- Arranging reference/ impurity standards to respective manufacturing unit for qualification.
- Preparing SDS in compliance with REACH and GHS label requirements.