As a PPD FSP Clinical Research medical Advisor you may support a variety of designated therapeutic areas including Cardio-Renal-Metabolic/Immunology/Neuroscience.
Participation in Trade Association calls in listening & learning, observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases.
Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team
The incumbent will be responsible for performing analytical method development and validations for USP/NF monographs and maintaining safety and GLP environment in the lab.
Having Injectable Experience of Shop floor supervising activities like Filling, Sealing, Stoppering, Garment Washing Machine, Vial Washing, Autoclave, Ophthalmic, Suspensions, filtration, Lyophilizes. Operations and Training and QMS.
genetically modified pancreatic islet cells transplanted into a man with type 1 diabetes, without the need for immune-suppressing drugs. For twelve weeks, the cells survived, produced insulin, and functioned naturally.
Masters in Natural or Agricultural or Pharmaceutical Sciences, MVSc, Animal Sciences. Doctoral Degree in Science, Pharma, MD, MS from a recognized University.
In-depth knowledge of cGMP, WHO, ISO, USFDA, and other applicable regulatory guidelines. Strong leadership in QMS implementation, audit management, and team building.
MPharm in any Pharmacy discipline or PharmD. Preference will be given to candidates with background and exposure in pharmacometrics modeling. Additional benefit: Selected candidate may register for PhD under Manipal Academy of Higher Education (MAHE), Manipal on fulfilling the prescribed eligibility criteria.
M.Sc. (Life Science) or equivalent degree holders [M.Sc (Agriculture), MBBS, BDS, MVSc/ M.Pharma/ B.E./ B.Tech] with 1st class in graduate and post-graduate examination with basic knowledge of computers (word. Powerpoint, excel)
Doctorate (Ph.D.) in the relevant subject (Molecular Biology / Genetics / Pathology / Microbiology / Biochemistry / Pediatrics / Medicine / Medical Oncology) from a recognized university.
Post Graduate Degree in Life Sciences (Zoology, Biotechnology, Biochemistry, Microbiology, etc.,) or Post Graduate degree in professional courses (M. Tech in Life Sciences, M. VSc. Etc.). or B. V. Sc.