Senior Executive, Regulatory Affairs
Senior Executive role at Amneal Pharmaceuticals focusing on regulatory affairs for sterile pharmaceutical dosage forms. The role involves managing IND, NDA, and ANDA submissions, developing CMC strategies, and ensuring compliance with FDA and ICH guidelines. Candidates will oversee the full lifecycle of regulatory activities and interact with US-based teams. The position requires 5-8 years of experience and deep expertise in sterile injectable/ophthalmic dosage forms.
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Experience
5-8 years
Function
Research
Work mode
Onsite, India
Company
Tier 2
What you will work on
Senior Executive role at Amneal Pharmaceuticals focusing on regulatory affairs for sterile pharmaceutical dosage forms. The role involves managing IND, NDA, and ANDA submissions, developing CMC strategies, and ensuring compliance with FDA and ICH guidelines. Candidates will oversee the full lifecycle of regulatory activities and interact with US-based teams. The position requires 5-8 years of experience and deep expertise in sterile injectable/ophthalmic dosage forms.
TAL's take
Solid role within an established pharmaceutical firm, requiring specific domain expertise in regulatory affairs for sterile dosage forms.
JD is highly specific, detailing exact submission types, dosage forms, and regulatory compliance requirements.
Must haves
- Experience in Sterile dosage form ANDAs
- Expertise in Aseptic or Terminal sterilization techniques
- Compile and submit IND, NDA and ANDA submissions
- Develop CMC regulatory strategies
- Working knowledge of ICH, FDA and 21 CFR regulations
- Proficiency in MS Office suite and Adobe Professional
Tools and skills
About the company
Established pharmaceutical company with significant global operations but not a flagship software/tech entity.