Regulatory Affairs

4 weeks ago

Ambernath, India Disha Skill Training Services Full time

QUALIFICATIONS:-

B.PHARMA / M.PHARMA


PHARMA REGULATORY


Skills


Analytical

.Time management

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.