A) Must have complete knowledge of dossier filling from start to finish. Must have experience in Module 1, 2, 3, 4.
B) Literature search for development phase of drug product
C) Day to Day communication with Different Departments of the Plant as well as client/agents for submission of dossier in a timely manner.
D) Has understanding of all regulatory pathways for Dossier Submissions and can compile eCTD dossier.
E) Management of Regulatory Database, Product Life cycle and review of commercial documents.
F) Identify variation categories for post-approval activities and compilation, review and submission of variation in a timely manner.
Required Qualification:
> B. Pharm/ M. Pharm/ M.Sc
Job location:
> Head Office, Thaltej, Ahmedabad.
If you have relevant experience, can apply on the same.
Thanks & Regards,
Yash Bharucha
Assistant Manager - Corporate HR
CORONA Remedies Ltd., Ahmedabad.
