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Sr Executive/Assistant Manager | Regulatory Affairs – US | Biocon Ltd | Bengaluru


Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Sr Executive/Assistant Manager – Regulatory Affairs – US

Location: Bengaluru, Karnataka, India

Job Description:

  • Hands-on experience specifically in the US market.
  • Should have liaised with the US colleagues or through the consultant
  • Expertise in the US registration having registered at least 3-5 Dossiers successfully
  • Thorough knowledge of the US requirements
  • Capable of anticipating potential queries and also should be well versed in Risk mitigation
  • Good communication, negotiation skill, Collaboration
  • Highly disciplined, matured and with a positive attitude

Qualification: B.Pharma/M.Pharma

Experience: 4-8 years of Relevant Experience

Salary: Negotiable

Contact Details:

Ms. Pranjali Waghaye


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