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The Regulatory Manager is a scientific leadership role that leads the regulatory activities involved in the India, Srilanka, Nepal, Maldives market. The role provides the regulatory strategies, and regulatory submissions of new products for various brands in Rx, OTC, Food supplements in support of the new and existing portfolio

Mammalian and Microbial (Upstream Process): Media preparation, Filtration, Aseptic technique, Inoculum Handling, Handling of SU bioreactor/RM, Perfusion technology, upstream analytical instruments. Handling of SS Fermenter, Continuous centrifuge

Ointment, General Manufacturing & Sterile Manufacturing, Granulation, Compression, Coating, Capsule

Experience in handling equipment like Reactor, Centrifuge, ANFD, Multimill, Micronisation, Sparkler filters, Technology Transfer for scale up at Pilot Plant. Handled finished goods store, Dispatch, Export, Domestic Knowledge of E-Way Bill, customs, GST.

Regulated markets and currently working as a shift incharge. Experience in compression, granulation and should possess expertise in Quality Management System (QMS) production.

Sterile manufacturing Suspension/emulsion /PFS / BFS as well as SKID operation. Should have experience in Aseptic process, complex manufacturing, Exposure to CIP/ SIP SKID, QMS.

Compile registration dossiers for submission to various health authorities like – USA, Canada, Europe, Australia and Israel. Prepare responses to deficiency letters received from various agencies.

For all the positions, it is essential for candidates to have exposure in Injectable Sterile plant and regulatory requirements of documentation as per cGMP/GLP.

Must have exposure in handling of Process Area maintenance like Manufacturing Vassals, Filling machine, Autoclave , Isolators and Lyophilization