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Regulatory Manager-Reputed Healthcare Industry

10.00 to 15.00 Years   Pune   25 Jul, 2023
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

    SALARY: 15 LPA QUALIFICATION: Phd/Msc or Masters in Biotechnology/Stem Cells/Cell Theraphy/Biopharma MALE/FEMALE: Male EXPERIENCE: 10 Years to 16 Years 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,

Keyskills :
stem cellscell therapyregulatory agenciessafety pharmacology

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