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Manager, Toxicology at Amneal India
Ahmedabad, gujarat, India -
Full Time

Start Date

Immediate

Expiry Date

03 Aug, 26

Salary

0.0

Posted On

05 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Non-clinical Toxicology Strategy, In vivo Toxicology, In vitro Toxicology, Pharmacokinetics, Pharmacodynamics, Safety Risk Assessment, Impurity Qualification, Regulatory Compliance, IND/CTA Submissions, Human Risk-Benefit Evaluation, Leachables and Extractables Assessment, Non-animal Methodologies

Industry

Pharmaceutical Manufacturing

Description
Description: The position is responsible for non-clinical toxicology strategy and execution supporting drug discovery and development programs. The role develops and oversees in vivo and in vitro toxicology studies to evaluate safety, toxicology, pharmacokinetics, pharmacology, pharmacodynamics, and efficacy of drug products. The role performs toxicological and safety risk assessments by integrating generated and published data to support human risk–benefit evaluation. The position leads impurity qualification using animal and in vitro toxicity studies to meet global regulatory requirements and also supports non-animal novel methodologies for impurities, leachables, and extractables. The role ensures scientifically sound and regulatory-compliant non-clinical safety decisions. Essential Functions: * Design and manage in vivo and in vitro toxicology studies * Evaluate toxicology, PK, PD, and safety pharmacology data * Perform toxicological and safety risk assessments * Support human risk–benefit evaluation using non-clinical data * Lead impurity qualification toxicity studies * Assess leachables and extractables toxicological risk * Apply non-animal alternative methodologies where appropriate * Interpret internal and published toxicology data * Prepare regulatory non-clinical safety documentation * Support IND/CTA and global regulatory submissions * Collaborate with DMPK, pharmacology, and clinical teams Additional Responsibilities:
Responsibilities
Responsible for designing and managing non-clinical toxicology strategies and studies to evaluate the safety and efficacy of drug products. The role involves performing risk assessments and preparing regulatory documentation for global submissions.