Chemical Compliance Specialist

2 weeks ago

Noida, Uttar Pradesh, India beBeeCompliance Full time ₹ 14,40,000 - ₹ 2,01,12,000
Regulatory Affairs Manager

We are seeking a skilled Regulatory Affairs Manager to maintain compliance with domestic and international regulations, ensuring our products meet the required chemical control laws.

Key Responsibilities:

  • 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 single point of contact for DMF filing and regulatory activities in various geographies.
  • Manage the complete life cycle of DMF/Dossiers for APIs/active ingredients/intermediates, including filing, access requests, technical queries, change notifications, and amendments.
  • Coordinate with internal teams on DMF filing requirements and ensure data readiness.
  • Review relevant documents and DMF prior to filing to ensure a right-first-time approach.
  • Address customer and regulatory queries within tight timelines through collaborations with internal CFTs.

Additional Responsibilities:

  • Pre-register and register chemicals under EU REACH, Korea REACH, UK REACH, Turkey REACH, and other similar regulations.
  • Upgrade or downgrade registered tonnage bands as per business requirements and maintain dossiers accordingly.
  • Assess new product regulatory requirements and provide guidance to business and R&D teams on compliance strategies.
  • Maintain and monitor export volumes of products through the ERP system to comply with registered volumes in respective countries.
  • Review Safety Data Sheets and labels of hazardous products.
  • Provide regulatory inputs on customer queries and questionnaires.

Requirements:

  • Master's degree in Toxicology, Pharmacology, Biochemistry, Chemistry, or other life sciences.
  • 7-12 years of experience in regulatory affairs, preferably in the pharmaceutical or chemical industry.

Location: Noida

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