Compliance Officer

19 hours ago


Kanpur, Uttar Pradesh, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000
Regulatory Affairs Specialist

The role of a Regulatory Affairs Specialist is pivotal in ensuring compliance with international guidelines and country-specific requirements. This involves preparing, reviewing, and maintaining regulatory documents to guarantee seamless operations.

This specialist will be responsible for screening and analyzing documents received for product registration requests as per country-specific guidelines, including prioritizing dossiers to meet defined timelines and ensuring timely submission to the regulatory authorities.

Key areas of responsibility include drafting and coordinating responses to regulatory queries with appropriate documentation and justifications, arranging supportive batch-related documents, and managing legalization or apostillation of registration documents.

In addition, this role will support the Compliance team by providing updated documents required for technical file preparation, periodically review and update Technical Master Files to ensure consistency across product categories, and coordinate with cross-functional teams to fulfill regulatory requirements.

  • Graduate/Postgraduate degree 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.
  • Detail-oriented, with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Good written and verbal communication skills.


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