USV Pvt Ltd – Executive – Regulatory Affairs – Solid Orals – US Market
Post – Executive – Regulatory Affairs
Qualification – Any Graduate in Any Specialization
Experienced – 3 – 6 Years
Location – Mumbai( Govandi )
Submission of controlled correspondence to USFDA for IID Limits, stability study design, BE study design, RLD designation etc.
Co-ordinate, Collate and Conduct review of relevant standard technical documentation like specification, stability, PDR, method validations, BMR, BPR as per the USFDA requirements.
Compilation of high quality dossier in line with the current requirement of USFDA for various solid oral dosage forms specifically IR Tablets, MR Tablets, Capsule dosage forms.
Assist in resolution of queries / deficiency received from customer / USFDA, and timely submission of response to query /deficiency.
e-CTD compilation/ publishing of Dossiers and Submission to customer / USFDA.
Preparation and review of labeling/artwork/SPL .
Review and regulatory impact analysis of the changes notified by the vendors as well as evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable with USFDA to ensure regulatory compliance (Post-approval Life Cycle Management