MANAGER/ SR. MANGER

Candidate should have experience in US regulatory affairs in Peptide Injectables

1. Experience in filing strategy of peptide injections
2. Experience in Regulatory requirements at product development stage and exhibit stages
3. Experience in filing ANDAs, deficiencies and life cycle management and ANDA approval process
4. Experience in product launch regulatory requirements
5. Should have well awareness of US regulatory guidance's
6. Experience in implementation of guidance's requirements in filing
7. Should have decision making skills and good communication skills

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Hetero is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. It is also among the world’s leading producers of key Active Pharmaceutical Ingredients with presence in 145+ countries and backed by 30 years of experience in the pharma sector.