Works closely with the Global Regulatory Lead, Regulatory Affairs Manager providing the submission strategy and with the Submission Manager executing the submissions.
In this role, you will perform coding activities on the assigned project in a timely and efficient manner, code the Medical Conditions and Medication terms in the Coding tool, generate Queries to clarify in order to facilitate coding, and participate in study related meetings as needed.
Scientists at the National Eye Institute and their colleagues have identified a gene responsible for some inherited retinal diseases, which are a group of disorders that damage the eyes light-sensing retina and threatens vision. Though IRDs affect more than 2 million people worldwide, each individual disease is rare, complicating efforts to identify enough people to study and conduct clinical trials to develop treatment.
A team led by scientists at UC Riverside, UC Irvine, and Yale School of Medicine has now designed a new drug against malaria and identified its mechanism of action. The researchers found the drug, called MED6-189, is effective against drug-sensitive and drug-resistant P. falciparum strains in vitro as well as in a humanized mouse model the mice were engineered to have human blood.
1st Class M.Sc. in Biochemistry, Pharmacology, Chemistry, Sports Science, Medicine from recognized University, College, institutes with 8 years of experience in technical administration, management preferably in Anti Doping OR PhD in Biochemistry, Pharmacology, Chemistry, Sports Sciences, Medicine from recognized University, College, institutes
M.Pharmacy; M.V.Sc. in any Veterinary subject preferably in Veterinary Public Health, M.Sc. Life Sciences, experience of working on antibiotics/ pesticide residues detection, handling of the chromatographic instruments likely High Performance Liquid Chromatography HPLC, Gas Chromatography GC and Mass Spectrometry and High Performance Liquid Chromatography.
As a Pharmacologist, Toxicologist, the incumbent is responsible for reviewing and evaluating drug applications and communicating conclusions with a multidisciplinary review team. The work will be performed within any of the pharmacology, toxicology or clinical drug review divisions located within OND.
Develop and refine study designs to ensure scientific rigor and alignment with research objectives. Analyse data according to study statistical plan tailored to the studys specific needs, ensuring that data collection methods align with intended analysis strategies.
M.Sc. Biotechnology Microbiology, M.Tech, B.Tech Biotechnology Bioprocess Engineering, M.Pharm
Experience 3-10 years of experience in Drug Substance and Drug Product and In-Process Quality Assurance, QMS Deviation, Change Control, CAPA, Investigation, APQR, CPV, Process Validation, and Cleaning Validation