Toxicologist

Role Description

This is a full-time on-site role for a toxicologist based in Hyderabad. The toxicologist will be responsible for the non-clinical overview of pharmaceutical products. The ideal candidate will possess expertise in toxicological assessment, regulatory compliance, and non-clinical safety data analysis. This role involves collaborating with cross-functional teams to support drug development and regulatory submissions

1. Non-Clinical Safety Assessments:

• Evaluate and interpret non-clinical safety data, including toxicology, pharmacology, and pharmacokinetics studies, to ensure the safety and efficacy of pharmaceutical products.
• Conduct risk assessments related to human exposure to drugs based on non-clinical data.

2. Regulatory Documentation:

• Prepare and review the toxicology sections of non-clinical overviews (Module 2.4) and summaries for regulatory dossiers (e.g., INDs, NDAs, MAAs, and CTDs).

• Ensure all documentation complies with ICH guidelines and relevant regulatory requirements.

3. Study Design and Oversight:

• Collaborate with preclinical teams to design and oversee toxicology studies, including acute, sub-chronic, chronic, reproductive, developmental, genotoxicity, and carcinogenicity studies.

• Ensure studies adhere to GLP standards and regulatory expectations.

4. Cross-Functional Collaboration:

• Partner with pharmacologists, regulatory affairs professionals, and clinical teams to provide toxicological insights throughout the drug development process.

• Offer scientific advice and risk mitigation strategies for potential toxicological issues.

5. Regulatory Interactions:

• Represent the organization in communications with regulatory agencies regarding toxicology data and risk assessments.

• Respond to regulatory questions and provide justifications for non-clinical data.

6. Monitoring Scientific Developments:

• Stay updated on advancements in toxicology, regulatory guidelines, and industry best practices.

• Apply innovative methods to enhance non-clinical safety assessments.

7. Environmental risk assessment of medicinal products for human use. 

Education:

Years of Experience

Technical Skills

• Strong knowledge of toxicology study designs and GLP principles.
• Familiarity with regulatory frameworks (FDA, EMA, ICH, OECD).
• Proficiency in interpreting and presenting complex toxicological data. 

Other Skills:

• Excellent written and verbal communication skills.
• Strong organizational and project management abilities.
• Ability to work independently and collaboratively in a dynamic environment.

hiring@masuuglobal.com