Manager/Sr Manager – US Regulatory | Hetero Drugs | Hyderabad

Job Description

The candidate should have experience in US regulatory affairs in Peptide Injectables

  • Experience in filing strategy of peptide injections
  • Experience in Regulatory requirements at the product development stage and exhibit stages
  • Experience in filing ANDAs, deficiencies and life cycle management and ANDA approval process
  • Experience in product launch regulatory requirements
  • Should have well awareness of US regulatory guidance’s
  • Experience in implementation of guidance’s requirements in filing
  • Should have decision making skills and good communication skills

Qualification: B.Pharma, M.Pharma

Location