Toxicologist - Regulatory module writing
Toxicologist - Regulatory module writing
WNS (Part of Capgemini)
Job description
WNS is hiring a Toxicologist with regulatory module writing experience in Gurgaon, offering a great career opportunity for toxicology and pharmacology professionals in drug safety and regulatory documents.
Company Description
WNS is a part of Capgemini. It is a leader in operations and transformation. It uses AI to provide services. WNS helps more than 700 clients; these clients are in 10 industries. WNS has knowledge of AI platforms and analytics. These tools help businesses grow. They also help businesses change and improve. WNS has operations in 13 countries. It has 65 delivery centers and more than 66000 employees all, around the world.
Job Summary
This role is for a Toxicologist with regulatory module writing experience, at the Assistant Manager level, full-time in Gurgaon. The person will carry out toxicology risk checks for pharma, consumer health, and combination products. The job includes checking for impurities according to ICH rules, writing toxicology reports, and getting non-clinical parts ready for documents. People applying need 3 to 5 years of experience.
Key Responsibilities
Carry out risk assessments for pharma, consumer health, and combination products to meet global rules.
Check impurity limits as per ICH guidelines, including genotoxic and process-related impurities.
Review toxicology papers, safety databases, regulatory guidance, and published studies to support product safety decisions.
Write toxicology reports, risk assessment papers, expert opinions, and content for submissions.
Lead the preparation and review of non-modules for regulatory dossiers.
Give reasons for toxicology endpoints, safe daily exposure limits, impurity limits, safety margins, and ways to lower risk.
Support submissions with toxicology summaries, risk and benefit reviews, and replies to agency questions.
Study non-published data to support impurity checks, extractables checks, leachables checks, and product safety profiles.
Track global rules and guidance such as ICH, FDA, EMA, and WHO that relate to toxicology and impurities.
Educational Qualification
A PhD or M.Sc. in toxicology, pharmacology, or life sciences is needed.
Candidates should have 3 to 5 years of experience in toxicology, safety assessment, or regulatory toxicology in the pharma, consumer health, or life sciences industry.
Skills Required
Hands-on experience in impurity checks and toxicology reviews of drug substances and products.
Proven experience in writing and reviewing toxicology modules for CTD and eCTD submissions.
Strong knowledge of ICH guidelines, especially M7, Q3A, and Q3B.
Skill in literature reviews, safety assessments, and scientific reasons for regulatory files.
Excellent scientific writing and interpretation skills.
Strong stakeholder management skills.
Salary Structure
The average annual salary of a Regulatory Toxicologist at WNS typically ranges from ₹8 Lakhs to ₹12 Lakhs per year.
Career Development
This role builds strong skills in regulatory toxicology and dossier writing within a large global operations company. It can help you grow into senior manager or wider regulatory and safety science leadership roles over time.
How to Apply
Visit our job portal and search for the Toxicologist with Regulatory Module Writing Experience role at WNS.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
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