Regulatory Manager-Reputed Healthcare Industry @ Ad Astra

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

Employement Category:

Employement Type: Full time
Industry: Recruitment Services
Role Category: Bio Tech / R&D / Scientist
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Manager-Reputed Healthcare Industry

Contact Details:

Company: Seven Consultancy
Location(s): Pune

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Rs 0 - 50K PM Rs 50K - 1 LPA Rs 1.0 - 1.5 LPA Rs 1.5 - 2.0 LPA Rs 2.0 - 2.5 LPA Rs 2.5 - 3.0 LPA Rs 3.0 - 3.5 LPA Rs 3.5 - 4.0 LPA Rs 4.0 - 4.5 LPA Rs 4.5 - 5.0 LPA Rs 5 - 6 LPA Rs 6 - 7 LPA Rs 7 - 8 LPA Rs 8 - 9 LPA Rs 9 - 10 LPA Rs 10 - 12 LPA Rs 12 - 14 LPA Rs 14 - 16 LPA Rs 16 - 18 LPA Rs 18 - 20 LPA Rs 20 - 22 LPA Rs 22 - 24 LPA Rs 24 - 26 LPA Rs 26 - 28 LPA Rs 28 - 30 LPA Rs 30 - 32 LPA Rs 32 - 34 LPA Rs 34 - 36 LPA Rs 36 - 38 LPA Rs 38 - 40 LPA Rs 40 - 42 LPA Rs 42 - 44 LPA Rs 44 - 46 LPA Rs 46 - 48 LPA Rs 48 - 50 LPA Rs 50 - 75 LPA Rs 75 Lakh - 1C PA Rs 1 Crore+ PA

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Keyskills:   stem cells cell therapy regulatory agencies safety pharmacology drugs cosmetics