Regulatory Affairs Specialist

13 hours ago

Davangere, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,70,000

Job Title: Regulatory Affairs Manager

 

The primary goal of this role is to prepare, review, and maintain regulatory documents in compliance with international guidelines and country-specific requirements.

This position involves coordinating with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and adherence to regulatory standards.

Key Responsibilities:

  • Screen and analyze documents received for product registration requests according to country-specific guidelines.
  • Compile and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to the regulatory authorities.
  • Prepare and coordinate responses to regulatory queries with supporting documentation and justifications.
  • Arrange supportive batch-related documents (e.g., COA) for registration samples.
  • Manage legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments/invoices.
  • 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.
  • Collaborate with cross-functional teams (Quality, Production, R&D, and Compliance) to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.

Requirements:

  • Graduate/Postgraduate degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
  • 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Attention to detail, excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Effective written and verbal communication skills.

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