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Senior Executive Regulatory Affairs

Talentmate

India

8th September 2026

2609-5537-833

Job Description

JD:

Scientific review of external API vendor’s DMFs in context of global ANDA/NDA & resolving any gaps.
Preparation & review of ANDA/NDA Drug Substance Modules for submission to FDA & related activities.
Participation in project meetings, coordination with CFTs, effective communication & coordination.
Supporting Europe & Canada market projects for Drug substance part, as required.
Knowledge of current regulatory guidelines is required.
Experience of complex APIs will add value.
Knowledge of using AI in routine work will add value.

Local candidate is preferred.

Job Details

Role Level:	Mid-Level	Work Type:	Full-Time
Country:	India	City:	Ahmedabad ,Gujarat
Company Website:	http://www.amneal.com	Job Function:	Business Development
Company Industry/ Sector:	Pharmaceutical Manufacturing

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About the Company

Searching, interviewing and hiring are all part of the professional life. The TALENTMATE Portal idea is to fill and help professionals doing one of them by bringing together the requisites under One Roof. Whether you're hunting for your Next Job Opportunity or Looking for Potential Employers, we're here to lend you a Helping Hand.

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