4-5

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and, or regional perspective.

Regulatory Affairs professionals with 5 to 8 years of experience in regulatory strategy, dossier review, and submission for the US, EU, and Brazil markets.

Responsible for designing overall marketing and communication strategy of brands. Sales & Market data analysis. Knowledge of product strategy, product launch.

Plan and execute experiments in agreement with quality risk management and GDevP, GMP -Assists in the preparation of and reviews of the technological part of dossier

Experience in Validation Protocol, Report, QMS, Vendor Qualification. Experience in Method Validation

Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC, IR,UV instrument. Knowledge of Dissolution tester, KF, Potentiometer.

Collaboration with internal and external media to ensure the proper execution of strategies. Providing training, product knowledge, and direction to the field sales team to ensure that they are well-equipped with scientific and communication skills both.

Monitor the API, formulated products against stipulated conditions mentioned in the batch production record. Conduct certification of batch production records for compliance and stage wise completion.

B.Pharm, M.Pharm, B.E, B. Tech with 6 to 10 years of experience in Supervising and Controlling Production areas like Aseptic Filling, Vial Washing, Autoclave, Lyophilizer, Visual Inspection and Packing. Should have knowledge of QMS activities