Job title: Associate Director Regulatory Affairs – Business Continuity
Company: Abbott
Job description: Key accountabilities : * Managing regulatory compliance and business continuity of existing products of EPD India +ex India (Srilanka , Nepal, Bhutan, Maldives +++) in Drugs, FSSAI, Ayush, Vaccines, Cosmetics , Consumer OTC in Retail and Instituti
Key accountabilities : Managing regulatory compliance and business continuity of existing products of EPD India +ex India (Srilanka , Nepal, Bhutan, Maldives +++) in Drugs, FSSAI, Ayush, Vaccines, Cosmetics , Consumer OTC in Retail and Institution business (around1600 SKUs) in Plants (Baddi/Goa ), Loan License, Own, Imported ,TPK, In licensed product Responsible for all license renewals both at FDA and DCGI for all existing products of EPD India which is around 1600 both local and global products Responsible for alignment of all new regulations with respect to Drugs, Foods ,Cosmetics and Ayush products Responsible for maintaining updated database on all products of EPD India with respects to licenses , IP compliance and labelling compliance . Risk matrix to be monitored on real time basis with risk mitigation in plan to avoid any business continuity Work closely with RA compliance and RA external stakeholders team to ensure all compliances of new and existing regulations of existing products Responsible for DCGI regularization of all products which are currently not DCGI approved . Work with QA team on IP compliance of all existing products Responsible for all product , site renewals of international products and compliance with the changing regulations of all products sold in these markets ((Srilanka , Nepal, Bhutan, Maldives +++) All products complaints , market complaints to be addressed satisfactorily in close collaboration with EPO, legal, and QA Responsible for compliance of both plants u2013 Baddi and Goa and products compliance in these plants Responsible for all FDA licenses for both new and existing products Work closely with EPO and QA team for internalization of all products and support M&P activity Responsible from RA on all Change control management related to existing products One point of contact for all State FDA and Zonal CDSCO offices Responsible for all Vaccines clearance with CDTL Qualification : Education M.Pharm/Degree in Regulatory Affairs Experience 18-20 years in overall RA management both India andu00A0 EX India. Financial : Maintain business continuity of all EPD India products @ 1 BN
Expected salary:
Location: Mumbai, Maharashtra
Job date: Thu, 16 Dec 2021 23:10:31 GMT
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