Chemical Regulations Manager

3 days ago

Noida, Uttar Pradesh, India beBeeRegulatory Full time US$ 15,00,000 - US$ 24,00,000

Job Overview

We are seeking an experienced Regulatory Compliance Specialist to lead our product regulatory activities globally. The successful candidate will be responsible for ensuring compliance with domestic and international chemical regulations, monitoring new legislation, and developing strategies to mitigate risks.

Key Responsibilities:

  • Regulatory Compliance & Monitoring:
    • Ensure compliance with existing domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals.
    • Proactively monitor, evaluate business impact and communicate new and amended legislation and regulations.
    • Act as a point of contact for DMF filing /amendment in various geography.
    • Ensure complete life cycle management of DMF /Dossiers for APIs/active ingredients/intermediates, such as DMF filing, access request, address technical queries of agency & customers, change notification, LOAs, and amendment.
    • Manage a database and RA filing plan across the product value chain in various geography
    • Coordinate with internal teams on DMF filing requirements and ensure readiness of all data.
    • Review of relevant documents and DMF prior to filing and ensure right first time filing approach
    • Addressing customer/regulatory queries within timeline with the help of internal CFT collaborations
  • Pre-registration / Registration of chemicals and Maintenance:
    • Responsible for preparation & filing of pre-registration and registration dossiers of chemicals under EU REACH, Korea REACH, UK REACH, Turkey REACH etc.
    • Upgrading / downgrading registered tonnage band as per business requirement and maintenance of the dossiers as per the current requirements.
  • Assessment of New Product Regulatory Requirements:
    • Provide regulatory guidance/consultancy to the business and R&D teams on compliance strategies for new and existing products.
  • Substance Volume Tracking:
    • Responsible for maintaining and monitoring the export volume of the products through the ERP system to comply with the registered volume in the respective countries.
  • Hazard Communication:
    • Review of Safety Data Sheets & Labels of the hazardous products.
  • Customer Queries & Questionnaires:
    • Provide regulatory inputs on the customer queries & questionnaires.

Requirements: To be successful in this role, you will need a Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry or other life science and 7-12 years of experience in a similar field.

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