Aurobindo Pharma is one of the leading Indian pharmaceutical research companies that manufactures and export drugs and formulations worldwide.
Job Title : Research Scientist – Regulatory Affairs Department
No.of.Posts : 5
Experience : 3 – 5 Years
Location : Hyderabad
Job Description:
Technical Job Description
*Lead the preparation of filing of regulatory submission.
*Compilation of Dossiers
*Responding to Queries
*Raising and approving change controls
*Should be well versed with the guidelines of ICH and other regulatory.
*Preparation of documents for license application, COPP, FSC and other legal documents.
*Should be well versed with the preparation of registration documents as per ACTD, CTD, and country format.
*Preparation of text matter and checking of artworks.
*Should coordinate with factory for samples, working standards, document data, license related documents
*Responding to Queries
*Raising and approving change controls
*Should be well versed with the guidelines of ICH and other regulatory.
*Preparation of documents for license application, COPP, FSC and other legal documents.
*Should be well versed with the preparation of registration documents as per ACTD, CTD, and country format.
*Preparation of text matter and checking of artworks.
*Should coordinate with factory for samples, working standards, document data, license related documents
Education:
- Candidate should be from Pharma Industry
- Having interest in shifting their career towards regulatory affairs.
- Should have technical exposure on regulatory markets
- Technically strong ( Ability to cope up technical expectation of current team which has the credit of highest ANDA fillings ( 400+ highest among Indian Pharma Companies ).
- UG -B.Pharma
- PG – M.Pharma
