Regulatory Manager-Reputed Healthcare Industry-Pune, Maharashtra, India- 15 LPA-Harshala
1 day ago
JOB DETAILS Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activitiesSchedule 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 Regulatory Affairs Manager, Regulatory Manager, Quality Assurance, QA, QA Head, Head Quality, Regulatory Affairs Executive, Regulatory Affairs, Quality Assurance Manager, CMC, Stem Cells Theraphy, Cells Therapy, Biopharma, Biotechnology, Jobs for Regulatory Manager in Healthcare Industry, Jobs for Regulatory Manager in Pune, Healthcare placement agencies in Pune, Healthcare Recruitment agencies in Pune, Healthcare placement agencies in Pune, Healthcare Recruitment agencies in Pune, Healthcare placement agencies in Maharashtra, Healthcare Recruitment agencies in Maharashtra, Healthcare placement agencies in India, Healthcare Recruitment agencies in India, placement consultancy in Pune, best placement consultancy in Pune, top placement consultancy in Pune, placement consultancy in India, best placement consultancy in India, top placement consultancy in India. Apply Now
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Pune, India Seven Consultancy Full timeJOB DETAILS Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activitiesSchedule 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...
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Pune, India Seven Consultancy Full timeJOB DETAILS Manage Pharmaceutical and biological documentation & Registration application for chemical active substances, biological medicinal products & data control activitiesSchedule 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...
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1 day ago
Pune, India Seven Consultancy Full timeJOB DETAILS Keep front desk tidy and presentable with all necessary material (pens, forms, paper etc.)Greet and welcome guests Answer questions and address complaints Answer all incoming calls and redirect them or keep messages Receive letters, packages etc. and distribute them Prepare outgoing mail by drafting correspondence, securing parcels etc. Check,...
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