Officer - RA (API)
2 weeks ago
Job Description
- Review of outsourced DMF and deal with suppliers for adequate data for ANDA/MAA/ ANDS filings.
- Responsible for arranging the documentation required for regulatory submissions to US/Europe/ all other geographies - new DMF submissions Amendments, Response to Deficiencies.
- To provide Regulatory inputs during product development, manufacturing, and testing and to evaluate all types of change proposals during product life cycle.
- Responsible for evaluating the regulatory impact for the change notifications received from Outsource API vendors.
- Participate in selection process of supplier through audits from regulatory compliance viewpoint for new supplier & AVD.
2-3 Years in API Regulatory Affairs
DMF filing and handling regulatory agency queries
Education Masters in Chemistry Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation-
Mumbai, Maharashtra, India Kopran Full time ₹ 15,00,000 - ₹ 25,00,000 per yearRole & responsibilitiesPreparation of DMFs for regulated (US, EU) & ROW markets.Preparation of lifecycle management submissions (amendments / revisions) for the filed DMFs.Preparation of response to deficiencies from regulatory authorities & customers.Coordination with cross functional teams for data / documents.Preferred candidate profileCandidate should be...
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Central Supply Planning Manager
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