Assistant Manager / Deputy Manager – Toxicology (Global Nonclinical Development)
Location: Ahmedabad, Gujarat, India
Employment Type: Full-Time
Department: Global Toxicology & Nonclinical Development
Job Category: Preclinical / Non-Clinical Development
Experience Required: 7–12 Years
Job Overview
We are hiring an Assistant Manager / Deputy Manager – Toxicology to support global nonclinical development activities with a strong focus on safety assessment and risk evaluation. This role is critical in enabling the development of generic, complex generic, and specialty pharmaceutical products by providing scientifically robust toxicology expertise across multiple dosage forms.
The position involves independent scientific leadership, regulatory-facing documentation, and close collaboration with cross-functional and global stakeholders to ensure compliance, scientific integrity, and patient safety.
Key Responsibilities
Toxicology & Risk Assessment
Lead toxicological safety and risk assessments for drug substances, impurities, excipients, and extractables & leachables (E&L).
Establish health-based exposure limits, including Permitted Daily Exposure (PDE) and Occupational Exposure Limits (OEL).
Conduct n-nitrosamine risk assessments in line with global regulatory expectations.
Regulatory & Scientific Documentation
Author and review expert toxicology reports supporting ANDA, NDA 505(b)(2), and complex generic submissions.
Support regulatory filings across oral, injectable, topical, and other dosage forms.
Ensure all documentation meets global regulatory standards and scientific best practices.
Study Oversight & Alternative Methodologies
Manage outsourced preclinical toxicology, PK/PD, and mutagenicity studies.
Ensure compliance with GLP standards, animal welfare regulations, and ethical research practices.
Implement and evaluate alternative toxicological methodologies, including in silico (Q)SAR modeling and non-animal approaches.
Cross-Functional Collaboration
Work closely with global teams across R&D, Regulatory Affairs, Quality, CMC, and Nonclinical Development.
Provide toxicology input to support project strategy, development timelines, and risk mitigation.
Contribute to internal scientific discussions and decision-making forums.
Required Qualifications & Experience
Education
Master’s or Doctoral degree in Toxicology, Pharmaceutical Sciences, Veterinary Sciences, Biomedical Sciences, or related disciplines (M.Pharm, MS, MSc, MVSc, BVSc, PhD).
Experience
7 to 12 years of relevant experience in toxicology, nonclinical development, or preclinical safety assessment within the pharmaceutical or biotech industry.
Prior experience supporting generic or complex generic drug development is highly preferred.
Certifications (Preferred)
Board certification such as DABT, ERT, or equivalent is an advantage but not mandatory.
Key Skills & Competencies
Strong knowledge of toxicology, risk assessment, and regulatory science
Hands-on experience with (Q)SAR tools, impurity qualification, and nitrosamine assessments
Excellent scientific writing and regulatory documentation skills
Ability to manage multiple projects independently in a fast-paced environment
Strong communication, stakeholder management, and cross-functional collaboration skills
High level of scientific integrity, attention to detail, and problem-solving ability
Why Join Us
This role offers the opportunity to work at the forefront of global nonclinical development, contributing directly to the safe and compliant development of high-quality medicines. You will collaborate with international teams, gain exposure to complex regulatory pathways, and play a key role in advancing patient safety through science-driven decision-making.
SEO Keywords for Global Visibility
Toxicology jobs India, Nonclinical Development roles, Assistant Manager Toxicology Ahmedabad, Preclinical Safety Scientist jobs, Pharmaceutical Toxicologist India, ANDA NDA toxicology roles.
Equal Opportunity Statement
The organization is an equal opportunity employer and is committed to building an inclusive workplace that values diversity, equity, and mutual respect. All qualified applicants will receive equal consideration for employment without discrimination.
Disclaimer
This job description is intended to describe the general nature and level of work performed and does not represent an exhaustive list of responsibilities. Duties may evolve based on business and regulatory needs.
Gujarat :
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Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
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Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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