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

1 week ago


Pune, India Seven Consultancy Full time
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 CGMPMaintain Cell Therapy guidelines, USFDA guidelines, EMAAnimal Safety & efficacy studies with GLP certified laboratory/testing facility (Preclinical and non-clinical related activities)Knowledgeable in CPMP-ICH or CPMP guidelinesExperience in Process Validation and Manufacturing Process DevelopmentExperienced in Validation of Analytical Procedures and Stability DataAdventitious Safety Evaluation and Process Validation Scheme for the Drug ProductShould have knowledge in validation of analytical methods and analytical methodologyExtensive knowledge of Pharmacology, Pharmacokinetics, Pharmacokinetics, Toxicokinetic, Toxicology, Genotoxicity, Carcinogenicity, Local ToleranceKnowledge expert in Safety pharmacology studies for human pharmaceuticalsKnowledge expert in Single dose toxicity and repeated dose toxicityEnsure Clinical trial and prepare Clinical Study ReportsEfficacy and Safety StudiesShould have Post-Marketing ExperienceStatutory fulfillmentPresent and conduct meetings with regulatory agencies, CROs, national & international authoritiesReporting weekly, monthly, quarterly, yearly meetings, updates, improvementsFUNCTIONAL AREARegulatory 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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