Officer - RA (API) (Santacruz, MH, IN) bei Lupin

Job Description

1. Review of outsourced DMF and deal with suppliers for adequate data for ANDA/MAA/ ANDS filings.
2. Responsible for arranging the documentation required for regulatory submissions to US/Europe/ all other geographies - new DMF submissions Amendments, Response to Deficiencies.
3. To provide Regulatory inputs during product development, manufacturing, and testing and to evaluate all types of change proposals during product life cycle.
4. Responsible for evaluating the regulatory impact for the change notifications received from Outsource API vendors.
5. Participate in selection process of supplier through audits from regulatory compliance viewpoint for new supplier & AVD.

Work Experience

2-3 Years in API Regulatory Affairs

DMF filing and handling regulatory agency queries

Education

Competencies