Looking to advance your career in toxicology, drug safety, and regulatory sciences? Here’s an excellent leadership opportunity in the pharmaceutical industry.
Amneal Pharmaceuticals is hiring a Manager – Toxicology for its Ahmedabad location. This role is ideal for experienced professionals with strong expertise in toxicological risk assessment, regulatory submissions, and preclinical research.
Job Overview
- Position: Manager – Toxicology
- Company: Amneal Pharmaceuticals
- Location: Ahmedabad, Gujarat
- Experience: 10–12 Years
- Qualification: M.Pharm / M.S. / MVSc / BVSc / M.Sc / PhD (Toxicology or Biomedical Sciences)
Key Responsibilities
- Conduct Toxicological Risk Assessments (TRA)
- Evaluate product impurities and nitrosamine safety
- Establish PDE (Permitted Daily Exposure) & OEL (Occupational Exposure Limits)
- Provide regulatory toxicology support for NDA/ANDA submissions
- Manage CROs for preclinical toxicology studies
- Ensure GLP compliance and scientific documentation
Required Skills & Expertise
✔ Strong knowledge of toxicology & drug safety evaluation
✔ Experience in regulatory guidelines (USFDA, ICH, etc.)
✔ Hands-on exposure to nitrosamine risk assessment
✔ Expertise in preclinical study management & CRO coordination
✔ Excellent analytical and scientific writing skills
Why Join Amneal Pharmaceuticals?
✔ Work with a globally recognized pharmaceutical company
✔ Opportunity to contribute to innovative drug development
✔ Exposure to regulatory submissions and global standards
✔ Leadership role in toxicology and safety sciences
✔ Career growth in high-impact R&D functions
Who Should Apply?
- Professionals with 10–12 years of toxicology experience
- Candidates from pharma R&D, regulatory, or preclinical backgrounds
- Experts in risk assessment, impurities, and safety evaluation
- Individuals seeking senior-level scientific leadership roles
Important Dates
- Last Date to Apply: 30 June 2026
Apply Now
Frequently Asked Questions (FAQs)
Q1: What qualification is required for this role?
Candidates must have M.Pharm, M.Sc, MVSc, BVSc, MS, or PhD in Toxicology or related biomedical sciences.
Q2: What is the experience requirement?
A minimum of 10–12 years of relevant toxicology experience is required.
Q3: Is regulatory experience important?
Yes, experience in NDA/ANDA submissions and regulatory toxicology is highly preferred.
Q4: Where is the job location?
The role is based in Ahmedabad, Gujarat.
Q5: What are the key focus areas of this role?
Toxicological risk assessment, nitrosamine evaluation, PDE/OEL setting, and preclinical study management.
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