Compliance Expert

19 hours ago

Madurai, Tamil Nadu, India beBeeregulatory Full time ₹ 8,00,000 - ₹ 12,00,000
Regulatory Affairs Specialist Job Opportunity

We are seeking an experienced Regulatory Affairs Specialist to drive the preparation, review, and maintenance of regulatory documents ensuring compliance with international guidelines and country-specific requirements.

  • Key Responsibilities:
  • Screen and analyze documents received for product registration requests according to country-specific guidelines.
  • Prepare, compile, and review product dossiers in compliance with customer and regulatory requirements.
  • Prioritize dossiers to meet defined timelines and ensure timely submission to regulatory authorities.
  • Draft and coordinate responses to regulatory queries with appropriate documentation and justifications.
  • Arrange supportive batch-related documents (e.g., certificates of analysis) 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.
  • Coordinate 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
  • Bachelor's or Master's degree in a relevant field such as 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 Microsoft Office (Word, Excel, PowerPoint) and document management systems.
  • Good written and verbal communication skills.
Skills Required
  • 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.
  • Document management and record-keeping skills.
About Us

We are an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

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