Regulatory Affairs Specialist

15 hours ago

Salem, Tamil Nadu, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000
Regulatory Affairs Specialist

The Regulatory Affairs Specialist will play a pivotal role in ensuring compliance with international regulatory guidelines and country-specific requirements.

  • Main Responsibilities:
  • Analyze documents received for product registration requests to ensure adherence to country-specific guidelines.
  • Prepare, compile, and review product dossiers to meet customer and regulatory needs.
  • Prioritize dossiers to meet defined timelines and guarantee timely submission to regulatory authorities.
  • Draft and coordinate responses to regulatory queries with supporting documentation.
  • Arrange necessary batch-related documents for registration samples.
  • Manage the 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.
  • Regularly review and update Technical Master Files to ensure consistency across product categories.
  • Collaborate with cross-functional teams to fulfill regulatory requirements and address audit queries.

Essential Skills and Qualifications:

  • Bachelor's/Master's 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.
  • In-depth 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.

Required Skills:

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

Behavioral Competencies:

  • Strong attention to detail and accuracy.
  • Able to work effectively under pressure and meet strict deadlines.
  • Team player with strong collaboration and coordination skills.
  • Proactive, adaptable, and willing to take initiative.

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