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Walk in interview for M.Pharm, B.Pharm, MSc in Regulatory Affairs Department at Biocon-24th February 2024, Saturday

Biocon
Pharmacareer

Website Biocon

About Biocon

Biocon is a leading global biopharmaceutical company that is dedicated to improving the lives of patients in over 120 countries. The company focuses on developing new and cost-effective treatments for prevalent health challenges such as diabetes, cancer, and autoimmune diseases. As a research-driven organization, Biocon operates globally in the healthcare sector, possessing a robust set of capabilities across the biopharmaceutical value chain. With a commitment to innovation and a comprehensive approach to healthcare, Biocon strives to make a positive impact on global health by providing accessible and effective solutions for patients around the world.

Job Opportunities in Regulatory Affairs at Biocon – Bangalore

Join Our Regulatory Affairs Team and Shape the Future of Healthcare!

Department: Regulatory Affairs

  1. Formulation RA US / Canada – Pre-Approval
    • Experience & Education: 6-10 years; 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)

  2. Formulation RA Global Post-Approval

    • Experience & Education: 2-8 years; 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

  3. Formulation RA Global Labelling

    • Experience & Education: 1-4 years; B.Pharm
    • Job Profile:
      1. Management of labeling- & 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 labeling activities

  4. API RA DMF Submission

    • Experience & Education: 5-14 years; 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

Walk-in Interview

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

Important:

  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, a certificate of their highest educational qualification, the latest increment letter, and the last three months’ pay slips.

Interested candidates can email their resumes to upendra.kamma@biocon.com for an interview opportunity.

Biocon is an equal opportunity employer committed to diversity and inclusion.

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To apply for this job email your details to upendra.kamma@biocon.com