Regulatory Manager-Reputed Healthcare Industry-Pune, Maharashtra, India- 15 LPA-Sonali-8657493492
1 day ago
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 Tolerance
Knowledge expert in Safety pharmacology studies for human pharmaceuticals
Knowledge expert in Single dose toxicity and repeated dose toxicity
Ensure Clinical trial and prepare Clinical Study Reports
Efficacy and Safety Studies
Should have Post-Marketing Experience
Statutory fulfillment
Present and conduct meetings with regulatory agencies, CROs, national & international authorities
Reporting weekly, monthly, quarterly, yearly meetings, updates, improvements
FUNCTIONAL AREA
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