Pharma Documentation Specialist

2 weeks ago

Hyderabad, Telangana, India beBeeDocumentation Full time ₹ 10,35,000 - ₹ 15,60,000

Job Overview:

  • Professionals in this role ensure they have a thorough understanding of FDA documentation, both domestic and export-related.
  • They must be able to multitask effectively and possess excellent communication skills to interact with FDA authorities and overseas customers.
  • This involves planning, executing, and managing priorities for FDA activities as per requirements.
  • The ideal candidate stays updated on local and state FDA authorities' requirements and guidelines.
  • Key responsibilities include coordinating with the FDA for new applications and renewals, including loan manufacturing licenses, NOCs, test licenses, product permissions, COPP, FSC, NSQ, WHO-GMP, and other technical documents.
  • Supporting the regulatory department in timely availability of valid legal documents is also essential.
  • Preparing and submitting replies to queries raised by FDA authorities is another critical task.
  • Providing feedback related to FDA documents to the marketing department is also required.
  • Playing a key role in planning and executing all FDA-related work at various stages is crucial.
  • Coordinating with facilities to support the regulatory team and maintaining records is also an important aspect of this role.

Functional Area: Professionals in this role will be working in the medicine manufacturing industry, focusing on FDA documentation, and will be responsible for coordinating with facilities and supporting the regulatory team.

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