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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 Manufacturing Associates(Freshers and early-career professionals are encouraged to apply.)- B.Tech / M.Sc / M.Tech in Biotechnology or related Life Sciences discipline

Join the Team Building India's Largest Viral Vector Manufacturing Facility (500L+) Cellogen Therapeutics is hiring  Manufacturing Associates to join their Cell & Gene Therapy - Lentiviral Vector Manufacturing Team.
Be part of a pioneering mission to scale advanced viral vector manufacturing in India.
Details of the available position is provided below 
1. Open Position: Manufacturing Associates
(Freshers and early-career professionals are encouraged to apply.)
2. Eligibility Criteria:
B.Tech / M.Sc / M.Tech in Biotechnology or related Life Sciences discipline
-Knowledge of mammalian cell culture
-Understanding of molecular
biology techniques (PCR, qPCR, etc.)
-Familiarity with protein purification processes
-Prior experience in GMP/GLP facilities is an added advantage
3. Key Responsibilities:
-Execute upstream and downstream processing
-Support scale-up operations from 50L to 500L+ lentiviral vector manufacturing
-Maintain compliance with GMP protocols and quality standards
4. How to Apply: 
Interested candidates may also submit their application by completing the Form:
Send your resume to: info@cellogentherapeutics.com

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