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Senior Manager - Regulatory Affairs

1.00 to 10.00 Years   Ahmedabad   20 Aug, 2026
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaLegal Support Services
EmploymentTypeFull-time

Job Description

    Role Overview- Department: Regulatory Affairs- Business Unit: R&D Dholka- Designation: AGM/Sr. Manager- Reporting To: President RATo 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 clear 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.

Keyskills :
australianeuroperegistrationre-registrationeu/uk/auscountriesdossiers

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