We are hiring for Assistant Manager Regulatory for Leading Pharma company in Baddi
Designation: Assistant Manager Regulatory Department
Experience:- Min 3 yr
• Experience in resolving the queries as requested by Customers and Regulatory Agencies.
• Experience in handling deficiencies arising from MOH and regulatory authorities.
• Critical review & Compilation of technical documents, TDP (technical document package).
• Wide knowledge and experience for review of manufacturing process validation & analytical method validation SOP's, stability protocols, specification, STPs, Master formula records (MFR's),PDR, check list for TTD's for necessary correction and implementation.
• Preparation of registration documents in various countries along with TSE/BSE,cGMP, etc and other certifications as per Regulatory requirements
• Timely follow up of technical queries of Drug Regulatory Authorities.
• Maintenance of Dossiers and Regulatory documents.
• Coordination with production, QC,CRD & R & D Dept. for regulatory requirements and controls.
• Coordination of customer audits & their Compliances.
• Vendor performance, qualification, & audit for API & Intermediates.
• Co-ordination with manufacturing sites and ensure compliance.
Interested candidates can share details to Ms.Ruby at email@example.com or can drop a call at 9569926032
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