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Opportunities: Job Openings in Pharma Regulatory Affairs at Biocon

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Opportunities: Job Openings in Pharma Regulatory Affairs at Biocon

Introduction

Biocon Limited, a renowned player in the pharmaceutical industry, is on the lookout for dynamic individuals to join their Regulatory Affairs department in Bangalore. This content brief provides details on various roles available, along with the date, time, and venue for the upcoming hiring event.

Job Vacancy Details

Formulation RA – US/Canada – Pre-Approval

Role

  • Post-Approval Formulation RA

Work Experience & Education

  • 6-10 years of experience
  • B Pharm/M Pharm

Job Profile

  1. Preparation, review & timely submission of ANDA in the US.
  2. Deficiency & life cycle management for products filed in the US.
  3. Provide necessary regulatory inputs to different cross-functional teams, including CMO & CDMO projects.

Formulation RA – Global Post-Approval

Role

  • Formulation RA Global Labelling

Work Experience & Education

  • 2-8 years of experience
  • B Pharm/M Pharm

Job Profile

  1. Preparation, review & timely submission of supplements/variations for global markets.
  2. Preparation, review & submission of post-approval deficiency management.
  3. Handle change control assessments to provide necessary regulatory inputs for changes/strategies proposed.
  4. Preparation, review, compilation & submission of PADER/PSURS & Annual Report for all approved products across geographies as applicable.

Formulation RA – Global Labelling

Work Experience & Education

  • 1-4 years of experience
  • B Pharm

Job Profile

  1. Management of labelling- & artwork-related activities for global markets (US/EU/UK and RoW).
  2. Handle change control assessments for the artworks.
  3. Hands-on experience in handling SPL software for labelling activities.

API RA DMF Submission

Work Experience & Education

  • 5-14 years of experience
  • MSc/M Pharm/B Pharm

Job Profile

  1. DMF submission to global markets & handling health authority queries.
  2. Handle post-approval changes.
  3. Provide regulatory input for new molecule development.
  4. Customer queries and support.

Hiring Event Details

  • Venue: Biocon Campus-Gate No. 1, Phase 1, 20th Km, Hosur Road, Electronic City, Bangalore-560100, Karnataka
  • Date: 24 February 2024, Saturday
  • Time: 9:00 am to 2:00 pm

Important Instructions

  1. Candidates who have attended an interview with Biocon Limited over the last six months are not eligible to apply.
  2. Candidates must carry their updated resumes, certificate of their highest educational qualification, latest increment letter, and the last three month’s pay slips.

Application Process

Interested candidates can email their resumes to [email protected] for an interview opportunity.

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