Regulatory Affairs Expert

7 days ago

Kozhikode, Kerala, India beBeeRegulatory Full time ₹ 16,00,000 - ₹ 22,00,000
Regulatory Affairs Expert

About the Role:

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

Key Responsibilities:

  • The role requires preparing, reviewing, and maintaining regulatory documents to ensure compliance with international guidelines and country-specific requirements.
  • It also involves prioritizing dossiers to meet defined timelines and ensuring timely submission to the regulatory authorities.
  • Additionally, the successful candidate will draft and coordinate responses to regulatory queries with appropriate documentation and justifications.

Requirements:

  • A Graduate/Postgraduate in Pharmacy, Life Sciences, Biotechnology, or a related discipline is required for this position.
  • The ideal candidate should have 3–6 years of relevant experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Strong understanding of global regulatory guidelines and dossier preparation is essential.
  • The role requires detail-oriented individuals with excellent organizational and analytical skills.
  • Proficiency in MS Office (Word, Excel, PowerPoint) and document management systems is necessary.
  • Good written and verbal communication skills are also required.

Why You'll Thrive:

  • You'll have the opportunity to work on diverse projects and collaborate with cross-functional teams.
  • This role offers a dynamic and challenging environment where you can grow professionally.
  • You'll be part of a team that values innovation, teamwork, and professional development.

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