Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.
Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.
Bachelors degree in any natural sciences. Experience with basic molecular biology and biochemical techniques, cell culture techniques, data analysis, and report writing. Ability and experience handling data
To implement, manage and ensure the functions of GCP, GLP Quality Assurance program that will assure all BA, BE studies and clinical studies to withstand regulatory scrutiny.
Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries.
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
Request for proposals for supporting Development, validation and pre-commercialization of products, technologies under i4 BIPP and SBIRI and PACE AIR & CRS from Industry and Academia
Candidate having experience in machine operation for Tablet, Capsule and Ointment production. Candidate having experience in different packing lines of OSD & Sterile manufacturing.
HPLC Analyst, Operation of HPLC, Troubleshooting, Analysis of all In-process, Intermediates, RM, PM, Finish Product, Stability samples and other analytical samples of lab. Operation of GC, IR, UV, KF, Auto titrator, SOR and Wet Lab analysis.
CTC is responsible for monitoring study conduct and progress, identifying, resolving and escalating risks, issues which may impact delivery of the study to the necessary quality, timeline and budget objectives.