Assistant Manager / Deputy Manager – Toxicology
Location: Ahmedabad City, Gujarat, India
Employment Type: Full-time
Industry: Pharmaceuticals / Toxicology / Nonclinical Development
Job Category: Global Toxicology & Nonclinical Development
Hot Job | Trending Opportunity
Job Overview
Amneal Pharmaceuticals is seeking a highly motivated Assistant Manager / Deputy Manager – Toxicology to support global nonclinical development programs. This role focuses on safety and risk assessment for generic and complex pharmaceutical products, including impurities, excipients, extractables and leachables (E&L), and nitrosamines.
The ideal candidate will play a critical role in regulatory-driven toxicological evaluations supporting ANDA, NDA 505(b)(2), and complex generics across multiple dosage forms.
Key Responsibilities
Lead safety and toxicological risk assessments for generic drugs, impurities, excipients, and E&L
Author and review expert toxicology reports and scientific risk assessment documents
Manage outsourced preclinical toxicology, PK/PD, mutagenicity, and genotoxicity studies
Implement and support alternative toxicological methodologies and non-animal testing approaches
Establish health-based exposure limits including PDE, OEL, and ADE
Perform in silico (Q)SAR evaluations and computational toxicology assessments
Conduct N-nitrosamine risk assessments in compliance with global regulatory expectations
Provide toxicology support for ANDA, NDA 505(b)(2), and complex generics submissions
Collaborate with global cross-functional teams including Regulatory Affairs, CMC, Clinical, and Quality
Ensure compliance with GLP standards, scientific integrity, and animal welfare regulations
Manage multiple projects independently in a fast-paced, deadline-driven environment
Required Qualifications
M.Pharm / M.S. / M.Sc / MVSc / BVSc / PhD in Toxicology or a related biomedical science discipline
7 to 12 years of relevant experience in pharmaceutical toxicology or nonclinical development
Strong knowledge of global regulatory toxicology requirements and risk assessment frameworks
Hands-on experience with impurities, nitrosamines, E&L, and complex generics is highly desirable
Preferred Qualifications
Board Certification as a Toxicologist (DABT, ERT, or equivalent) – Advantageous but not mandatory
Experience working in global, matrix-based pharmaceutical organizations
Key Skills & Competencies
Strong scientific and analytical mindset
Excellent written and verbal communication skills
Ability to prioritize and manage multiple deliverables independently
Collaborative approach with global cross-functional teams
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company committed to delivering high-quality, affordable medicines. We are an equal opportunity employer and do not discriminate on the basis of caste, religion, gender, disability, or any other legally protected status. We are dedicated to fostering a diverse, inclusive, and respectful workplace.
About the Team – Human Resources
The Human Resources team partners closely with business leaders to support current and future organizational needs. Key responsibilities include:
Executive Role: Strategic input into people-related business decisions
Audit Role: Ensuring legal compliance and best employment practices
Facilitator Role: Supporting talent acquisition, learning & development, performance management, and employee wellbeing
Consultancy Role: Advising managers on workforce planning and employee relations
Service Role: Keeping the organization informed and prepared for evolving employment legislation and labor market trends
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Canada |Quebec :
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Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Japan | Saitama |Tokyo :
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