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Product Safety & Regulatory Consultant

Product Safety & Regulatory Consultant

Evalueserve IndiaHaryāna, Republic Of India, IN
16 days ago
Job description

Elevate Your Impact Through

Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies.

With presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making.

We have 4,500+ talented professionals operating across 45 countries, including India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets such as Colombia, the Middle East, and the rest of Asia-Pacific.

Recognized by Great Place to Work® in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and open culture that prioritizes flexible work-life balance, diverse and inclusive teams, and equal opportunities for all.

Curious to know what it’s like to work at Evalueserve?

About Intellectual Property and Research & Development (IPR&D)

Evalueserve is a leading global provider of innovation intelligence and IP solutions. Our global team of world-class IPR&D analysts and innovation consultants work with a large customer base of leading Fortune 200 active clients offering insights, research, advisory, and consulting services to create some of the world’s most advanced products.

With two decades of expertise across diverse domains and search types, our unique in-house research development and innovation intelligence team comprising patent analysts, innovation intelligence specialists, technical specialists, licensing analysts, patent agents, and IP docketing specialists have a deep understanding of global regulatory trends and are adept at handling large patent portfolios. As a member of our team, you will have the opportunity to work alongside top industry experts across the entire innovation cycle and provide strategic insights to shape the future.

What you will be doing at Evalueserve

  • End-to-end project management with proven client-facing and internal communication skills.
  • Assist in defining project scope and objectives, resources allocation ensuring flawless execution of multiple projects.
  • Manage relationships with clients and relevant stakeholders.
  • Prepare comprehensive Common Technical Document (CTD) dossiers in compliance with international regulations and marketing submission requirements.
  • Develop and review reports on Health Based Exposure Limits (HBELs) such as (PDE / OEL / ADI) for various chemicals.
  • Conduct scientific literature searches to gather, analyze, and compile relevant scientific data from diverse clinical and non-clinical safety, and efficacy databases.
  • Evaluate the quality, produce data summaries, and draw conclusions for various toxicological endpoints such as systemic toxicity, genotoxicity, skin / eye irritation, sensitization, carcinogenicity, reproductive toxicity, developmental toxicity, and toxicokinetic, in accordance with guidelines / guidance established by OECD, ICH, and EPA.
  • Review and author hazard or safety assessments for various chemical products such as pharmaceuticals, cosmetics, nutraceuticals, agrochemicals, botanicals, and biomedical devices.
  • Draft environmental and ecotoxicity assessments pertaining to chemicals, specifically addressing factors like persistence, bioaccumulation, and toxicity.

What we’re looking for :

  • Proficient in drafting and reviewing non-clinical modules of CTD
  • Preparation of HBELs as per regulatory requirements.
  • Demonstrated expertise in writing and submitting hazard or safety documentation in compliance with various regulations such as EU, EPA, ICH, or FDA.
  • Familiar with a range of toxicology, pharmacology, clinical, and regulatory databases, as well as their search strategies, for the purpose of identifying high-quality data.
  • Demonstrates a comprehensive understanding of diverse toxicological studies and their principles in accordance with OECD guidelines.
  • Excellent interpersonal skills and effective written and verbal communication abilities.
  • Proficient in completing tasks within assigned areas of responsibility with accuracy and timeliness.
  • Exhibits attentive and active listening skills.
  • Demonstrates strong teamwork skills and logical reasoning.
  • Displays the ability to identify proactive approaches to contribute towards the firm's goals and mission.
  • Open to challenging existing practices by introducing innovative work methodologies.
  • Location - Gurgaon and Bangalore

    Interested candidate can share updated resume at swati.pradhan@evalueserve.com

    Want to learn more about our culture and what it’s like to work with us?

    Write to us at : careers@evalueserve.com

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    Product Consultant • Haryāna, Republic Of India, IN

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