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Assistant Manager, Regulatory Affairs at Amneal India
Ahmedabad, gujarat, India -
Full Time
Start Date
Immediate
Expiry Date
19 Aug, 26
Salary
0.0
Posted On
21 May, 26
Experience
10 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Scientific Review, DMF Analysis, ANDA/NDA Preparation, Drug Substance Modules, Technical Writing, Change Control Assessment, Regulatory Guidelines, Cross-functional Team Coordination, Due Diligence, API Knowledge
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
The role involves the scientific review of API vendor DMFs and the preparation of ANDA/NDA Drug Substance Modules. It also requires managing change controls, writing deficiency responses, and supporting due diligence projects for European and Canadian markets.
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About Us
- About Y-Axis
- Corporate Responsibility
- Careers
- Y-Axis Reviews
- Site map
TESTIMONIALS
- Success Videos
- Customer Reviews
- Social Reviews
- Our Success
BLOGS
- Immigration News
- Immigration Blog
- Overseas Jobs
- Visa Stories
INDIAN LANGUAGES
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- Tamil
- Gujarat
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- Marathi
- Kannada
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- French
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