27 Oct
SEVEN CONSULTANCY
Pune
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> JOB DETAILS
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> 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
> 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,
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▶️ Regulatory Manager-Reputed Healthcare Industry-Pune, Maharashtra, India- 15 LPA-Harshala
🖊️ SEVEN CONSULTANCY
📍 Pune