Executive - Regulatory Affairs (ROW)

4 days ago

Mumbai, Maharashtra, India FDC Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

We are seeking an experienced and detail-oriented Executive Regulatory Affairs (ROW) to join our Regulatory team. The ideal candidate will be responsible for preparing, reviewing, and submitting dossiers for semi-regulated and non-regulated markets, ensuring compliance with global regulatory requirements, and coordinating with internal departments and external stakeholders for product registration and documentation.

Key Responsibilities:

  • Prepare and compile regulatory dossiers for semi-regulated and non-regulated markets (ROW).
  • Respond to queries and deficiencies raised by the Ministry of Health (MOH) or buyers related to dossiers and submissions.
  • Coordinate the arrangement and dispatch of product samples, working standards, and other materials required for registration.
  • Gather and organize documentation required for tenders and complete relevant questionnaires accurately.
  • Liaise with manufacturing plants and cross-functional departments to obtain documents, samples, and data necessary for registration and submissions.
  • Support the Section Head in generating regulatory data and documentation as required by the Exports Department.
  • Ensure compliance with applicable international regulatory standards and maintain up-to-date knowledge of evolving global requirements.

Key Skills & Competencies:

  • Strong understanding of regulatory requirements for semi-regulated and non-regulated markets.
  • Excellent documentation, coordination, and communication skills.
  • Proficiency in dossier preparation, query handling, and submission tracking.
  • Ability to work collaboratively across departments and manage multiple projects simultaneously.
  • Attention to detail and strong organizational abilities.

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