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Hetero Biopharma have an opening for Regulatory Strategies (Biologics & vaccines)

Greeting from Hetero Biopharma have an opening for Regulatory Strategies (Biologics & vaccines)

Company Name: Hetero Biopharma Ltd

DRegulatory Affairs -Regulatory Strategies

Designation: Senior Manager/AGM – Regulatory Strategies

Experience: 10 to 15 yrs.

Job Location: Jadcherla (Telangana)

Job Responsibilities:

  • To lead the regulatory strategies for project management w.r.t to new and existing biosimilar (rDNA) product filing with regulated markets like US, EU & ICH countries.
  • To have a comprehensive understanding and experience of CMC, Non-Clinical and Clinical aspects for regulatory filing as per the US-FDA & EMA biosimilar requirement.
  • To understand and implement strategies for developmental studies for new product and existing products as per US-FDA and EMA requirements.
  • To plan and discuss the way forward with the cross functional teams for initiation of the technical developmental studies.
  • To study and implement the new product and regulatory strategies.
  • To lead the new product identification and diligence studies for techno – commercial assessment.

Application Process : interested Candidates share your CV to Edukondalu.m@heterodrugs.com, HDL3hr@heterodrugs.com

Hetero Biopharma have an opening for Regulatory Strategies (Biologics & vaccines)

Hetero Biopharma have an opening for Regulatory Strategies (Biologics & vaccines)