Torrent Pharma, the flagship Company of Torrent Group is one of the leading pharma companies of the Country. The Company was a pioneer in initiating the concept of niche marketing in India and today is ranked amongst the leaders in therapeutic segment of cardiovascular (CV), central nervous system (CNS), gastro-intestinal (GI) and women healthcare (WHC). The Company also has significant presence in diabetology, pain management, gynaecology, oncology and anti-infective segments.
Post : Biopharmaceutics (Clinical Research)
Experience : 02 to 05 years
Qualification : M.Pharm (Pharmacology)
Job Description :
• Literature search and designing of Bioavailability (BA) and Bioequivalence (BE) studies of oral & non-oral products (injectable, derma, ophthalmic etc.) towards different regulatory submission.
• Coordinating with the CROs in India and outside India for finalizing the BA/BE study proposals.
• Review of BA/BE study protocols and provide input with respect to Pharmacokinetic (PK) and general recommendations as per the respective guidance documents.
• To provide justification in response to queries raised by DCGI/respective regulatory agency on study protocols and NoC documents.
• Monitoring of pilot and pivotal BA/BE studies at CROs.
• Review and Evaluation of study results with respect to physicochemical, biopharmaceutics, pharmacokinetics, clinical and formulation aspects of the drug product.
• Preparation of scientific justification/note in support of BE study design/ protocol/ results for regulatory agencies for their concurrence or advice.
• Preparation and review of non-clinical and clinical overviews for regulatory agencies.
• Preparation of comprehensive justification/response to address the regulatory queries on submitted ANDAs/dossiers to various regulatory agencies.
• Participating in due diligence of in-licensing/ partnered product development/dossiers with respect to all above activities.
Job Location : R&D Centre - Gandhinagar, Gujarat
INTERESTED CANDIDATES CAN MAIL THEIR RESUME ON
meghamaheshwari@torrentpharma.com,
vilshashah@torrentpharma.com
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