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Regulatory Toxicologist
Regulatory ToxicologistSyngene • Bengaluru, Karnataka, India
Regulatory Toxicologist

Regulatory Toxicologist

Syngene • Bengaluru, Karnataka, India
28 days ago
Job description

JOB DESCRIPTION

Job Title : Regulatory Toxicologist

Department : Safety Assessment

Job Location : Bengaluru

About Syngene : Syngene () is an innovation-led contract research development and manufacturing organization offering integrated scientificservices 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

Mandatory expectation for all roles as per Syngene safety guidelines

  • Overall adherence to safe practices and procedures of oneself and the teams aligned
  • Contributing to development of procedures practices and systems that ensures safe operations and compliance to companys integrity & quality standards
  • Driving a corporate culture that promotes environment health and safety (EHS) mindset and operational discipline at the workplace at all times.
  • Ensuring safety of self and team-members by adhering to safety protocols and following environment health and safety (EHS) requirements at all times in the workplace.
  • Ensure all assigned mandatory trainings related to data integrityhealth and safety measures are completed on time by all members of the team including self
  • Compliance to Syngene s quality standards at all times

Core Purpose of the Role :

Working with BGRC Syngene in the field of regulatory toxicology.

Role Accountabilities

  • 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.
  • Syngene Values :

    All employees will consistently demonstrate alignment with our core values

  • Excellence
  • Integrity
  • Professionalism
  • Specific requirements for this role :

  • Experience
  • Demonstrated Capability
  • Education
  • Experience : 1-3 years

    Skills and Capabilities :

  • 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
  • Education : MSc / MPharma / MVSc

    Equal Opportunity Employer :

    It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and / or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodation for qualified individuals with disabilities

    Key Skills

    Hair And Beauty,Facilities,IT Support,Bank,Asp.Net MVC

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

    Yearly Salary Salary : 1 - 3

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    Regulatory • Bengaluru, Karnataka, India

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