Regulatory Affairs Specialist

7 days ago

Bhiwadi, Rajasthan, India beBeeRegulatory Full time ₹ 1,20,00,000 - ₹ 2,00,00,000
Job Description
  • We are seeking a detail-oriented and proactive individual to join our Regulatory Affairs team.
  • The successful candidate will be responsible for ensuring timely submissions to regulatory agencies and customers worldwide.
  • This role involves maintaining a well-organized and up-to-date regulatory filing system, including databases and chronologies, for easy tracking of changes made to documents submitted to agencies or partners.
  • The ideal candidate will proactively update existing internal regulatory guidelines and develop new ones as needed to ensure alignment with current requirements.
  • They will continuously stay informed about the latest regulations, guidance documents, and standards set forth by relevant bodies.

Key Responsibilities:

  • Analyze and respond to inquiries from regulatory agencies and customers worldwide.
  • Coordinate with technical departments like R&D, QA, QC, ADL, and Manufacturing for arranging documents required for preparation, compilation of Dossiers within defined timelines.
  • Manage the Registration Sample to deliver it to customers within defined timelines.
  • Timely submission of dossier post-approval submissions to various Regulatory Authorities and subsequent life cycle management.

Requirements:

  • A bachelor's degree in a related field.
  • Minimum 3 years of experience in regulatory affairs.
  • Strong knowledge of regulatory requirements and industry standards.

What We Offer:

  • A competitive salary and benefits package.
  • Ongoing training and development opportunities.
  • A dynamic and supportive work environment.

How to Apply:

Please submit your application, including your resume and cover letter, to us.

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