Regulatory Compliance Specialist

1 day ago


Kanpur, Uttar Pradesh, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title:

Regulatory Compliance Expert">

Job Description:

We are seeking a highly skilled Regulatory Compliance Expert to lead our product regulatory activities in various regions.

As a key member of our team, you will be accountable for ensuring compliance with domestic and international chemical regulations governing industrial chemicals, fine chemicals & specialty chemicals.

Responsibilities include proactively monitoring, evaluating business impact and communicating new and amended legislation and regulations.

Act as a single point of contact (SPOC) for DMF & Regulatory filing /amendment in various geography, like in US, EU, WHO, Japan, ROW , CDSCO etc.

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 data base 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 CFTs collaborations.

Key Accountabilities:

  • Regulatory Compliance & Monitoring
  • Pre-registration / Registration of chemicals and Maintenance
  • Assessment of New Product Regulatory Requirements
  • Substance Volume Tracking
  • Hazard Communication
  • Customer Queries & Questionnaires

Benefits:

This is an excellent opportunity to work with a leading organization and contribute to the growth and success of our business. If you have a strong background in regulatory compliance and excellent communication skills, we encourage you to apply for this exciting role.



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