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 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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