Regulatory Affairs Specialist

6 days ago

Kolkata, West Bengal, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 21,60,000

This role involves ensuring the preparation and review of regulatory documents to guarantee compliance with international guidelines and country-specific requirements.

Key responsibilities include:

  • Screening and analyzing documents for product registration requests according to country-specific guidelines.
  • Preparing, compiling, and reviewing product dossiers in accordance with customer and regulatory requirements.
  • Prioritizing dossiers to meet defined timelines and ensuring timely submission to regulatory authorities.
  • Drafting and coordinating responses to regulatory queries with supporting documentation and justifications.
  • Organizing supportive batch-related documents for registration samples.
  • Managing legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
  • Supporting the Compliance team by providing updated documents required for technical file preparation.
  • Periodically reviewing and updating Technical Master Files to ensure consistency across product categories.
  • Collaborating with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensuring timely preparation and submission of documents related to audit findings.

To excel in this position, you should possess:

  • A 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.
  • A strong understanding of global regulatory guidelines and dossier preparation.
  • Detail-oriented skills, with excellent organizational and analytical abilities.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Effective written and verbal communication skills.

This position offers:

  • Knowledge of international regulatory requirements and guidelines.
  • Expertise in dossier compilation, review, and submission processes.
  • The ability to prepare and analyze technical and compliance-related documentation.
  • Familiarity with audit documentation and regulatory query management.
  • Document management and record-keeping skills.

Suitable candidates will demonstrate:

  • Strong attention to detail and accuracy.
  • The ability to work effectively under pressure and meet strict deadlines.
  • Excellent collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.
  • Professional communication and interpersonal skills.

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