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.
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
looking for an expert in Formulation development of Oral Solid & liquid dosage forms of regulatory markets. To coordinate with various CROs and internal Formulation R&D and Formulation Analytical R&D on the technical aspects of product development activities from development to filing stage.