Title:  Engineering Head - API

Position: Engineering Head - API

Grade: General Manager

No. of Position: 1 No.

Qualification: B.E. / B.Tech (Mechanical)

Experience: 20+ years of API industries experience in the field of engineering services of Plant & Utility maintenance

Responsibilities :

1) Monitoring for Documents compilation activities for New product filing , Re-Registration/renewals from plant dossier filing , sample requirements etc.

2) Participation in Action plan discussion for queries from different Regulatory agencies and monitoring for submission of data/documents from plant.

3) Coordination with CRA, ADD, FDD, MSTG ,PMO ,Plant team and with other CFT Members for regulatory requirements related to Registration, Re-Registration, queries, and variation filing.

4) Product Life Cycle Management: Active participation in Change control committee meeting. – Discussion with different Stakeholders and decision for final variation category (After taking concurrence from CRA, Country RA and Customers if require).

5) Activities related to Variation management - Tracking of Variation filing, approvals and intimation to plant for implementation of changes.

6) Support plant for business continuity of products by filing variations wherever applicable.

7) Monitoring for circulation of Regulatory Approvals and commitment details to Plant Team for US and OAM and Approval package for emerging market.

8) Participation in all launch discussions with plant CFT , business team , CRA to identify gap & mitigation plan.

9) Circulation of Regulatory strategies and Guidelines, wherever applicable

10) Support plant during Regulatory Inspections.

11) Monitoring for Product permissions, test licences and lay out archival activities for Local FDA .