Research Scientist
Year Ahmedabad, Gujarat, India
Job Description
b'
Department
PTC - MORAIYA
Job posted on
Mar 06, 2024
Employment type
C-C6-Confirmed-R&D Executive
- Understanding of all relevant FDA guidance pertaining to 505(b)(2) products development
- Literature search focusing preclinical and clinical development programme
- Understanding and defining the rationale of unmet need for identified product
- Thorough understanding of disease physiology, preclinical safety pharmacology.
- Identifying appropriate CRO for conducting non-clinical POC, Toxicity, safety pharmacology studies, PK/PD studies in human, bioequivalence/bioavailability studies.
- Budgeting of preclinical and clinical studies
- Authoring and review of study plan, protocol, scientific justification, publication for non-clinical studies.
- Review the data of preclinical POC, bioavailability and bioequivalence studies and leading the discussion with different cross functional team and CRO.
- Authoring and review of clinical, non-clinical sections in IND, briefing package, Investigators Brochure and NDA for regulatory submission.
- Authoring scientific justifications, Pre-IND, IB, Briefing package, PDM documents.
- Monitoring of preclinical and clinical studies in India and overseas CROs
- Oversee local regulatory application submission and approvals
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Job Detail
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Job IdJD3256666
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear