Toxicologist

Company Description

For over 25 years, Swanand Consultancy Services (SCS) has been a leading consulting firm, providing comprehensive solutions across diverse industries. Our expertise spans industrial chemicals, biocides, agrochemicals, cosmetics & consumer goods, green biotechnology, pharmaceuticals, food, and environmental studies.

At SCS, we are committed to supporting businesses of all scales. Whether you're a large enterprise or a medium-sized company, we can tailor our services to meet your unique needs and regulatory requirements.

Role Description

Swanand Consultancy Services (SCS) is seeking a highly motivated and experienced Toxicologist to join our team in Mumbai. This is a full-time, on-site position where you will play a key role in client consultation and project execution.

Responsibilities:

• PDE and OEL Calculation for chemicals and pharmaceuticals

• Medical Writing like development of CTD Module 2.4, 2.6 and 4 preparations (Non-Clinical Overview and Summaries) for MAA, ANDA, NDA and NDA-505(b)(2) application.

• General Toxicological Risk Assessment for Chemicals, Pharmaceutical Active Ingredients, Medical Devises

• Biocompatibility evaluation of breathing gas pathways and E&L as per ISO 10993 & ISO 18562 (TI, TE, TSL, EEDmax & MOS calculation).

• Toxicity prediction using OECD QSAR Toolbox

• Data mining from public domain (Pubmed, Toxplanet, OVID, OCED SIDS, IUCLID, MHRA, NTP, FDA Orange Book, EMA, ECHA, EPA, INCHEM, Health Canada etc.)

• Cosmetic Product Safety Report Preparation

• SDS preparation

Qualifications

• Master's degree in Pharmacology or PhD with sound knowledge of Regulatory Toxicology Guidelines (OECD GLP, ICH Q3A, ICH Q3B, ICHQ3C, ICH Q3D, ISO 10993 & 18562 series and ICH M4 & M7)
• Understanding of Laboratory Skills
• Toxicology
• Regulatory Affairs
• Research and Development (R&D)
• Research
• Strong analytical and problem-solving skills
• Attention to detail
• Effective communication and collaboration skills
• Ability to work independently and as part of a team
• Experience in the relevant industry is a plus