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Required For Regulatory Affairs ( Biologics/Biosimilars for global markets including USFDA and EMA.) - M.Pharm / MSc / PhD (Biotechnology, Life Sciences or related)

Amneal Pharmaceuticals, Ahmedabad, Gujarat is  looking for experienced Regulatory Affairs  professionals with strong expertise in Biologics/Biosimilars for global markets including USFDA and EMA. They are seeking professionals with strong regulatory expertise, strategic thinking, and the ability to work in a cross-functional environment. This role involves end-to-end regulatory ownership across development, submissions, and lifecycle management for large molecule products. What they are  specifically looking for :  - Hands-on experience in regulatory submissions (IND/BLA/ANDA, IMPD/MAA) -Strong understanding of CMC for biologics (cell line, upstream/downstream, analytical, validation, comparability) -Experience with biosimilar regulatory pathways (USFDA 351(k), EMA) -Ability to handle regulatory queries, deficiency responses, and global lifecycle activities -Exposure to sterile/injectable or specialty biologics is an added advantage Qualification Required:  M.Ph...
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Required For Regulatory Affairs ( Biologics/Biosimilars for global markets including USFDA and EMA.) - M.Pharm / MSc / PhD (Biotechnology, Life Sciences or related)

Amneal Pharmaceuticals, Ahmedabad, Gujarat is  looking for experienced Regulatory Affairs  professionals with strong expertise in Biologics/Biosimilars for global markets including USFDA and EMA.
They are seeking professionals with strong regulatory expertise, strategic thinking, and the ability to work in a cross-functional environment.
This role involves end-to-end regulatory ownership across development, submissions, and lifecycle management for large molecule products.

What they are  specifically looking for : 
- Hands-on experience in regulatory submissions (IND/BLA/ANDA, IMPD/MAA)
-Strong understanding of CMC for biologics (cell line, upstream/downstream, analytical, validation, comparability)
-Experience with biosimilar regulatory pathways (USFDA 351(k), EMA)
-Ability to handle regulatory queries, deficiency responses, and global lifecycle activities
-Exposure to sterile/injectable or specialty biologics is an added advantage
Qualification Required: 
M.Pharm / MSc / PhD (Biotechnology, Life Sciences or related)
Experience: 
3-10 years of Regulatory Affairs experience (Biologics/Biosimilars)
Role Exposure Includes:
-Preparation and submission of global regulatory dossiers (CTD/eCTD) Regulatory strategy support for biosimilars/biologics development
-Handling post-approval changes, variations, and lifecycle activities
-Cross-functional collaboration with R&D, QA, Manufacturing, Clinical, and PV teams
-Supporting regulatory inspections and audit readiness
How to Apply: 
Relevant candidates may share their CV at
Nandini.Nair@amneal.com

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