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Assistant Manager, Regulatory Affairs at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, DMF Review, ANDA, NDA, Drug Substance Modules, Technical Writing, Deficiency Responses, Regulatory Guidelines, Complex APIs, AI Tools, Project Management, Cross-functional Coordination, Due Diligence, Scientific Review

Industry

Pharmaceutical Manufacturing

Description

* Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps. * Preparation & review of ANDA/NDA Drug Substance Modules & related activities. * Preparation of project status, strategy white papers & ppts for discussion in next level. * Technical writing of deficiency responses, modules & other scientific regulatory documents, as required. * Participation in project meetings, coordination with CFTs, effective communication & coordination. * Supporting Europe & Canada market due diligence 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.

Responsibilities

The Assistant Manager will conduct scientific reviews of API DMFs for ANDA/NDA submissions and resolve regulatory gaps. They will also prepare technical regulatory documentation and coordinate with cross-functional teams to support market due diligence.