Strategic Regulatory Specialist

2 days ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 15,00,000

Role Overview:

We are seeking an experienced Regulatory Affairs Executive to join our team in a highly regulated industry. The ideal candidate will have a strong understanding of international regulatory requirements and guidelines.

  • This role involves preparing, reviewing and maintaining regulatory documents for compliance with international guidelines and country-specific requirements.

Key Responsibilities Include:

  1. Screening and analyzing documents for product registration requests as per country-specific guidelines.
  2. Compiling and reviewing product dossiers in compliance with customer and regulatory requirements.
  3. Prioritizing dossiers to meet defined timelines and ensuring timely submission to the regulatory authorities.
  4. Drafting and coordinating responses to regulatory queries with appropriate documentation and justifications.
  5. Arranging supportive batch-related documents for registration samples.
  6. Managing legalization or apostillation of registration documents, including coordination with agencies, tracking timelines and processing payments/invoices.
  7. Supporting the Compliance team by providing updated documents required for technical file preparation.
  8. Periodically reviewing and updating Technical Master Files to ensure consistency across product categories.
  9. Coordinating with cross-functional teams to fulfill regulatory requirements and address audit queries.
Requirements:
  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review and submission processes.
  • Ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.

Preferred Qualifications:

  • Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology or a related discipline.
  • 3-6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.

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