1. Brief knowledge about MAs/ Formulation dossier filings of Drug products for successful approvals in ROW markets particularly AFRICA continent
2. Adequate knowledge of eCTD submission of formulated dossiers
3. Review and approval of Technology Transfer Documents / Site documents of New products, new projects
4. Close Coordination & follow up with internal & external stake holders for fast track submissions & approvals
5. Response to regulatory authority notices and quarries in time
6. Assist plant teams in regulatory audits, liaison with domestic & export regulatory authority.
7. Packing material (Art - work) recommendations and approvals as per regulatory provisions.
8. Ability to handle special & time bounded projects effectively
9. Ability & competency in handling external regulators directly
10. Willingness to travel abroad to interact with FDA regulators directly to bridge the gaps & to resolve issues.
Role:Regulatory Affairs Compliance
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional Area:Legal & Regulatory
Role Category:Corporate Affairs
Employment Type:Full Time, Permanent
UG:B.Pharma in Pharmacy
PG:M.Pharma in Pharmacy
Doctorate:Ph.D/Doctorate in Pharmacy
Hetero Drugs Limited
Contact Company:Hetero Drugs Limited
Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India