B.Pharm / M.Pharm; Preparation of responses to clarification requests received from Canadian authorities. Communicate with external suppliers for the preparation of packaging components and ensure technical feasibility.
Expertise in Molecular Biology, Cell Biology, Structural biology, Immunology. The candidate should also be familiar with studying Protein- small molecule interaction, Tissue culture techniques, animal handling, enzymatic assays, Immune phenotyping.
Perform all the labelling update activities and tracking in systems for record maintenance with respect to New Product Development NPD label creation and Product Life Cycle Management PLCM update for products in USA and Canada market
Assist in submission of product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and support in handling post-approval changes, maintenance, and updation of documents during the products life-cycle. Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by collation, and compiling documents in order to ensure approvals for launch in stipulated time
The Uttar Pradesh Subordinate Services Selection Commission (UPSSSC) is the state organization authorized to conduct civil service examinations for appointments to various Group C and Group D posts. The UPSSSC conducts various examinations within the state of Uttar Pradesh.
Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, under Department of Biotechnology (DBT), Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.
Senior Research Fellow to work on CCRAS-sponsored Evaluation of Coded drug Ayush Rasayana B for treatment of high-altitude sickness using multi-dimensional drug discovery approach project.
Should have detailed knowledge as well as experience of working for an injectable manufacturing process. Should have compendia and regulatory knowledge of aseptic processing and controls and Contamination control strategy program.