Bajaj Healthcare – Regulatory affairs Openings – Fresher & Experience

Bajaj Healthcare - Regulatory affairs Openings - Fresher & Experience
  • Full Time
  • Anywhere
  • ₹250000 - 300000 INR / Year
  • Salary: ₹250000 - 300000

Website Bajaj Healthcare ltd

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:

Bajaj Healthcare - Regulatory affairs Openings - Fresher & Experience
Bajaj Healthcare – Regulatory affairs Openings – Fresher & Experience

To apply for this job email your details to

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