Regulatory Affairs _ US Market (CMC, Module 3) Formulation _ Hyderabad

BVR People Consulting

6 - 11 years

10 - 13 Lacs

hyderabad

Posted:1 month ago| Platform:

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Skills Required

osd queries submission anda ra solid orals ctd regulatory affairs formulation m3 dossier cmc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Greetings!!!!

We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre.

Regulatory Affairs US Market (CMC)

Key Responsibilities:

Hands-on experience in
US Regulatory Affairs
for
ANDA & NDA (Approved and Tentative)
submissions.
Responsible for
filing supplements
: CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates.
Planning, reviewing, and timely submission of assigned projects in compliance with
FDA guidelines
.
Strong interpretation of
FDA queries
and drafting of high-quality responses.
Review and preparation of
CMC sections (Module 2 & 3)
.
Evaluation and interpretation of
post-approval changes
; preparation of related dossiers.
Review of
BMRs, specifications (drug product, drug substance, excipients), stability protocols
.
Preparation of
Annual Reports/PEPFAR updates
.
Ensure compliance with
high safety, quality, and regulatory standards
.

Desired Candidate Profile

M. Pharmacy (Pharmaceutics / Regulatory Affairs)
with 611 years of relevant experience.
In-depth knowledge of
USFDA regulatory requirements
.
Strong expertise in
CMC, post-approval changes, and supplements (CBE, CBE-30, PAS)
.
Excellent
drafting, reviewing, and query interpretation skills
.
Exposure to
ANDA/NDA lifecycle management
.

Interested Candidates Kindly Share your updated cv to uma@bvrpc.com

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