Regulatory Affairs Specialist Position

7 days ago

Agra, Uttar Pradesh, India beBeeRegulatory Full time ₹ 18,00,000 - ₹ 24,00,000

Regulatory Affairs Specialist Role Summary:

This is a specialized position that involves preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements. It requires collaboration with internal teams and external stakeholders for product registrations, timely dossier submissions, query responses, and compliance with regulatory standards.

Key Responsibilities:

  • Analyze and evaluate documents received for product registration requests according to country-specific guidelines.
  • Possess the ability to prepare, compile, and review product dossiers in accordance with customer and regulatory needs.
  • Demonstrate prioritization skills to meet defined timelines and ensure timely submission of documents to regulatory authorities.
  • Develop and coordinate responses to regulatory queries with supporting documentation and justifications.
  • Arrange necessary batch-related documents for registration samples.
  • Manage the legalization or apostillation of registration documents including coordination with relevant agencies, tracking timelines, and processing payments.
  • Support the Compliance team by providing updated documents required for technical file preparation.
  • Periodically review and update Technical Master Files to maintain consistency across product categories.
  • Collaborate with cross-functional teams to fulfill regulatory requirements and address audit queries.
  • Ensure timely preparation and submission of documents related to audit findings.

Requirements:

  • 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.
  • Strong understanding of global regulatory guidelines and dossier preparation.
  • Attention to detail with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems.
  • Effective written and verbal communication skills.

Behavioral Skills:

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

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