Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.
Retired para-medical staff in the relevant level or higher, within 65 years of age and having prescribed medical fitness, are eligible to apply. The employees who have retired in the relevant categories in higher pay levels, upto 3 levels higher than the posts being filled up through re-engagement
The applicant should possess an M.D./M.S./Ph.D. degree (M.D./M.S./M.D.S. or MBBS/BDS/MVSc./M.Sc./M.Pharma/M.Tech or equivalent with Ph.D. in health/biomedical research) with at least fifteen years of experience
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.
Are you passionate about quality and keen to build your career in the pharmaceutical industry? We are hiring enthusiastic and dedicated individuals for our Quality Control (QC) Department.
Exposure to OSD Manufacturing operations like Compression, Pellet coating, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will be added advantage.
Novartis has announced the top-line results of its Phase III GCAptAIN study, evaluating Cosentyx (secukinumab) in patients with giant cell arteritis (GCA) a serious inflammatory condition that primarily affects adults over the age of 50.
Merck has announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental Biologics License Application (sBLA) for Winrevair (sotatercept-csrk).
In a major scientific breakthrough, researchers from McMaster University, Cleveland Clinic, and the Case Comprehensive Cancer Center have uncovered how a protein commonly linked to Alzheimer’s disease also plays a critical role in the spread of lung cancer to the brain. The discovery could pave the way for repurposing existing Alzheimer’s drugs to halt or slow brain metastases in cancer patients.