Regulatory Manager-Reputed Healthcare Industry-Pune, Maharashtra, India- 15 LPA-Harshala

JOB DETAILS

Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activities
Schedule as per Drugs and Cosmetics Act, India GMP and USFDA CGMP
Maintain Cell Therapy guidelines, USFDA guidelines, EMA
Animal Safety & efficacy studies with GLP certified laboratory/testing facility (Preclinical and non-clinical related activities)
Knowledgeable in CPMP-ICH or CPMP guidelines
Experience in Process Validation and Manufacturing Process Development
Experienced in Validation of Analytical Procedures and Stability Data
Adventitious Safety Evaluation and Process Validation Scheme for the Drug Product
Should have knowledge in validation of analytical methods and analytical methodology
Extensive knowledge of Pharmacology, Pharmacokinetics, Pharmacokinetics, Toxicokinetic, Toxicology, Genotoxicity, Carcinogenicity, Local Tolera...