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