Department: Regulatory Affairs
Business Unit: R&D; – Dholka
Designation: Sr. Manager
Reporting To: President RA
Job Description:
•To review Registration and Re-Registration Dossiers before submission in all EU/UK/Aus/ NZ countries.
•To maintain Country-wise registered products status for all EU/UK/AUS/ NZ countries.
•To co-ordinate with other departments R&D;, QA and QC for ensuring the filling and Query responses.
•To provide technical support to team for preparation of Registration/Re- registration dossiers and Query responses.
•To prepare and review documents for Variation filling as and when required for all EU/UK/AUS/NZ countries.
•To explicit issues of Commercial Orders related to Regulatory department for EU/UK/Aus/NZ countries.
•To guide and give support for tenders to International SBU as per regulatory requirement (if any) for EU/UK/Aus/NZ countries.
•To review and resolve queries related to Contract manufacturing and due diligence, perform SAP related activity for this product.