Management & Leadership Jobs in Ahmedabad, India (Now Hiring) — 205 open

Key Responsibilities
• Nonclinical safety and toxicology study design & execution - 
1. Design, plan, and conduct in vivo and/or in vitro safety pharmacology and toxicology 
studies in alignment with GLP principles.
2. Select appropriate species, study duration, and endpoints based on pharmacology, 
pharmacokinetics and regulatory requirements.
3. Review study raw data, protocols, results and reports.
4. Oversee study execution, ensure data accuracy, and coordinate with CROs or internal cross 
functional teams.
• Risk Assessment & Safety Evaluation - 
1. Analyse and interpret the safety and toxicology data and integrate findings with pharmacokinetics and pharmacodynamics to assess potential safety risks.
2. Perform toxicological risk assessments including PDE/OEL/ADI derivations, impurity/excipient qualification assessments, extractables & leachables evaluations, and safety margin calculations.
3. Conduct exposure assessments for process materials, impurities, metabolites, degradation products and excipients.
• Regulatory & Documentation - 
1. Prepare and review high-quality safety and toxicology study reports, technical summaries, and nonclinical sections of regulatory submission documents (IND, NDA/MAA, ANDA, eCTD Modules 2.4/2.6 & 4, briefing books and IB, etc.).
2. Support regulatory filings to USFDA, EMA, DCGI, and other global agencies.
3. Draft and review regulatory query responses, briefing documents, and expert justifications.
• Toxicology Informatics & Literature Research - 
1. Perform comprehensive literature searches using toxicity databases (e.g., PubMed, TOXNET, ECHA, HSDB, etc.,).
2. Utilize modern toxicity prediction & risk assessment software/tools (e.g., DEREK Nexus, CASE Ultra, OECD QSAR Toolbox, etc.).
3. Interpret computational toxicology outputs and integrate them into safety evaluations.
• Compliance & Quality - 
1. Ensure full adherence to global regulatory guidelines (ICH, OECD, EMA, and USFDA).
2. Support internal audits, regulatory inspections, and quality compliance activities related to toxicology studies.
• Cross-Functional Collaboration
1. Work closely with Pharmacology, ADME, DMPK, CMC, Clinical and Regulatory Affairs teams.
2. Represent toxicology in project meetings and contribute to risk/benefit evaluations.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

 

Key roles that the Human Resources team performs:

 

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

 

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

 

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

 

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

 

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.