Bajaj Healthcare – Regulatory affairs Openings – Fresher & Experience

Bajaj Healthcare Ltd has an opening for Regulatory affairs Fresher & Experience Job Openings

listed Job Profile.

Department: Regulatory Affairs

Designation: RA – Officer

Education / Qualification: B Pharmacy

Experience: 0 to 1 year

Salary: As per company Standards

Job 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.

Application Process :  Interested & Eligible Candidates share your Resume to Email ID: hrd@bajajhealth.com