Sr Executive /Asst Mgr Regulatory Affairs Executive(API)Ankleshwar

Search Advisers Services Guj

6 - 11 years

6 - 13 Lacs

ankleshwar

Posted:1 week ago| Platform:

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Skills Required

regulatory affairs regulatory documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

anita.searchrx@gmail.com

Role & responsibilities

Preparation, compilation, and review of
Drug Master Files (DMFs)
and
Active Substance Master Files (ASMFs)
for submission to various regulatory authorities (USFDA, EDQM, TGA, PMDA, etc.).
Handle
query responses
from global regulatory agencies and ensure timely and accurate replies.
Coordinate with
R&D, Quality Assurance, Quality Control, and Production
teams for regulatory data collation.
Review of
technical documents
such as specifications, analytical methods, process descriptions, and stability data.
Support in the preparation of
Annual Product Reviews
and
Post-Approval Changes
.
Maintain and update
regulatory databases and tracking systems
.
Ensure compliance with
ICH, USFDA, and EU guidelines
for API documentation.
Support audits and inspections by regulatory authorities.
Ensure regulatory compliance throughout the product lifecycle.
Strong knowledge of
API regulatory guidelines
(USDMF, EDMF, CEP, WHO, etc.).
Understanding of
CTD format
and global submission requirements.
Good communication and coordination skills.

Preferred candidate profile

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