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HR at Nivagen Pharma (INDIA) Pvt. Ltd
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Nivagen Pharmaceuticals - Executive/Senior Executive - Regulatory Affairs - US/EU/Japan (4-7 yrs)
1. Author and compile CMC documentation for ANDA filings and post-approval submissions
2. Coordination with stakeholders on regular basis to source the documents in accordance with project timelines
3. Review the documents against the FDA guidances assuring regulatory compliance
4. Keep knowledge up to date with regard to regulatory guidelines
5. Hands-on experience on using eCTD software
6. With relevant exp in API- Hands on exp in DMF compilation, review , filing to authorities - Hands on exp in drafting responses to queries, on new products ROS evaluation and on regulatory markets (US/EU/Japan) requires, on eCTD, ICH guidelines, GMP
7. Should have experience in core Regulatory Affairs function, Good interpretation & applicability skills for ICH, ASEAN, EMEA. Understanding of regulatory needs /regulatory strategies. Handling the queries received from various Regulatory authorities
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