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Regulatory Affairs


Disha Skill Training Services


Location

Ulhasnagar | India


Job description

QUALIFICATIONS:-

B.PHARMA / M.PHARMA

PHARMA REGULATORY

Skills

Analytical

Presentation skills .

Interpersonal skills.

Experience-- 4-5 Years of Experience in Pharma Regulatory Affairs

Job Summary

Core understanding of technical requirements in the CTD

Coordinate with Plant and associated departments to facilitate the dossier

requirements.

Review of PVP PVR, Stability, PDR, BMR, and other directly or indirectly

linked Quality Section in CTD/ACTD

Preparing Dossiers, Review and Filling Dossiers.

Timely answering Queries raised by Authorities of EMEA- European Medical

Agency and customers to expedite the registration process.


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