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Job Description & How to Apply Below
Designation - Deputy Manager
Job Description:
Team member – In vitro In vivo toxicology .
Key Responsibilities:
Experimental Toxicology & Preclinical Research
Develop preclinical strategies supporting differentiated product development.
Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for NCE or complex/differentiated products, vaccines, biological products
Plan, outsource, oversee, and interpret impurity qualifications studies.
Plan, outsource, oversee, and interpret in vivo/ in vitro genotoxicity studies.
Plan, outsource, oversee, and interpret in vivo/ in vitro biocompatibility studies for medical devices.
Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products.
Summarize toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory authority submissions.
Qualifications and Skills
Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field.
Minimum 7-10 years of experience in experimental toxicology within the pharmaceutical, CRO or biotechnology industry.
Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions.
Proven ability to manage multiple projects simultaneously and work effectively in a dynamic team environment.
Excellent communication skills with the ability to collaborate cross-functionally and interact with external partners such as CROs.
Detail-oriented with proactive planning abilities, coupled with strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills.
Skilled in using computer software including Microsoft Office suite (Word, Excel, PowerPoint), SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications.
Operational details:
Location:
Vikhroli, Mumbai.
Mode:
Full time, work from office
Shifts:
General shift (8 hours)
Travelling:
Rare/Occasional for outdoor duties/ monitoring
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