Job Description

Vacancy for Regulatory toxicologist at Syngene International Ltd 2023.

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Organization	Syngene International Ltd
Post Name	Regulatory toxicologist
Job Location	Bengaluru
Official Website	https://www.syngeneintl.com/

Job Title/Position:

Regulatory Toxicologist (45161)

Job Overview:

Job vacancy for Pharmacy, Life Sciences, Toxicology

Job Location:

Bengaluru

What are the Key Responsibilities?

Working with BGRC Syngene in the field of regulatory toxicology.
Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients/API/ Pharmaceuticals used in consumer and OTC products.
Preparation and reviewing of Nonclinical overview for CTD submission of dossier filing.
Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals.
Conduct risk assessment for raw materials for cosmetic applications including Margin of safety calculations.
To derive Health Based exposure limit (PDE/OEL/DNEL/ADI) for Pharmaceuticals/ cosmetics/ nutraceuticals/ agrochemicals/ botanicals.
To provide evidence of efficacy and safety (preclinical and clinical) as per regulatory requirements.
Preparation of Safety Data sheet in compliance with GHS.
Scientific literature search-To extract, analyze and collate toxicology data from various clinical/toxicology/efficacy related databases like TOXNET, HSDB, PubMed, Medline, ScienceDirect etc.
To evaluate quality of different toxicity studies (such as systemic toxicity, genotoxicity, skin/eye irritation, sensitization, carcinogenicity, reproductive and developmental toxicity, toxicokinetic studies) as per OECD/ ICH /FDA/ISO guidelines.
To prepare research reports/ dossiers according to the international regulatory guidelines.

What are the Educational Qualification(s) for Regulatory toxicologist position(s)?

MSc/MPharm/MVSc

What is the Experience Required for this Job?

1-3 Years

What are the Preferred Skills required for this Job/Position?

All employees will consistently demonstrate alignment with our core values

Excellence
Integrity
Professionalism

Related:

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