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Assistant Manager, Regulatory Affairs at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

19 Oct, 26

Salary

0.0

Posted On

21 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Scientific Review, DMF Review, ANDA Preparation, NDA Preparation, Drug Substance Modules, Technical Writing, Change Control Assessment, Regulatory Guidelines, Cross-functional Team Coordination, Due Diligence

Industry

Pharmaceutical Manufacturing

Description

Qualification: M.Sc. Chemistry or M.Pharm Experience: 8 -15 yrs * 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 & updates for discussion in next level. * Assessment of change controls & vendor notifications. * Technical writing of deficiency responses, modules & other scientific regulatory documents, as required. * Participation in project meetings, coordination with CFTs, good 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

Responsible for the scientific review of API vendor DMFs and the preparation of Drug Substance Modules for ANDA/NDA submissions. The role involves managing deficiency responses, assessing change controls, and coordinating with cross-functional teams for global market due diligence.