Regulatory Affairs Specialist

17 hours ago


Rajkot, Gujarat, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

Regulatory Affairs Professional

About the Role
  • This key position is responsible for managing and preparing regulatory documents to ensure compliance with international standards.
  • The successful candidate will have a strong understanding of global regulatory guidelines and dossier preparation, allowing them to analyze documents received for product registration requests.

Main Responsibilities:

  1. Preparation and review of product dossiers in compliance with customer and regulatory requirements.
  2. Timely submission of dossiers to regulatory authorities while prioritizing tasks to meet deadlines.
  3. Drafting and coordinating responses to regulatory queries with supporting documentation.
  4. Collation of batch-related documents for registration samples.
  5. Management of legalization or apostillation of registration documents, including coordination with agencies and tracking timelines.

Key Requirements:

  • Bachelor's or Master's degree in a relevant field such as Pharmacy, Life Sciences, Biotechnology, or related discipline.
  • Minimum 3-6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
  • Excellent attention to detail and accuracy in work.
  • Ability to work under pressure and meet strict deadlines.
Benefits

This role offers opportunities for professional growth and development within a dynamic team that values collaboration and teamwork. A competitive compensation package is also provided.

Working Environment

This is an individual contributor role reporting directly to the Assistant Manager - RA. The working environment is supportive and encourages open communication and knowledge sharing.



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