After a journey of growth spanning 27 years as Cadila Healthcare Ltd. and the Zydus Group, we have evolved and transformed ourselves in response to the changing times. Our legacy of over 70 years in healthcare and being dedicated to life in all its dimensions is reaffirmed in our new mission, vision and purpose. Unifying ourselves under the Zydus name, Cadila Healthcare Ltd., is renamed as Zydus Lifesciences Ltd.
Post : Deputy Manager / Manager
Inviting candidates for the post of Deputy Manager / Manager for Biopharmaceutics and Clinical Development (Formulation R&D) for Pharmaceutical Technology Centre, Ahmedabad
M.Pharm / PhD / M. Sc. in Pharmacology and Toxicology with 5-10 years of experience in clinical and preclinical development for Formulation R&D.
Candidates would be responsible for the following tasks
Clinical and preclinical development of 505(b)(2) products :
• Literature search focusing on preclinical and clinical development programmes.
• Understanding and defining the rationale of unmet needs for identified product.
• Thorough understanding of disease physiology and preclinical safety pharmacology.
• Identifying appropriate CRO for conducting non-clinical POC, Toxicity, safety pharmacology studies, PK / PD studies in human and bioequivalence / bioavailability studies.
• Budgeting of preclinical and clinical studies.
• Authoring and reviewing of study plan, protocol, scientific justification and publication for non-clinical studies.
Candidates would also be responsible for the following tasks -
Clinical and preclinical development of 505(b)(2) products :
• Reviewing the data of preclinical POC, bioavailability and bioequivalence studies and leading the discussion with different cross functional teams and CROs.
• Authoring and reviewing of clinical, non-clinical sections in IND, briefing package, investigator’s brochure and NDA for regulatory submission.
• Monitoring preclinical and clinical studies in India and overseas CROs.
• Oversee local regulatory application submission and approvals.
Candidates would also be responsible for the following tasks – Genotoxicity / Toxicity studies :
• Outsourcing and overseeing all technical and regulatory aspects of AMES test (invitro, invivo tissue distribution studies) and toxicity studies.
• Reviewing of study data, study report and defining the strategy for the assessment of genotoxicity/toxicity study as per USFDA, ICH and OECD guidance.
• Managing the budget and financial aspects of CROs.
Additional Information
Experience : M.Pharm / PhD / M.Sc
Qualification : M.Pharm / PhD / M.Sc
Location : 5-10 years
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Biopharmaceutics and Clinical Development (Formulation R&D) for Pharmaceutical Technology
End Date : 10th February, 2024
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