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...
Auxilla Pharma is Hiring for Microbiology Department Details of the available position is provided below 1. Department: Microbiology (R&D) 2. Experience: 2 - 5 years 3. Qualification: M.Sc (Micro) 4. Job Location: Sanand, Ahmedabad, Gujarat 5. How to Apply: Interested candidates can mail CV to hr@auxillapharma.com 6. Benefits: a. 5 days working b. Transportation facility c. Food facility d. Mediclaim e. Accident insurance f. 9 days Diwali Vacation Note: Candidates willing to stay committed for at least 2/3 years shall only apply for the job. Click Here for Details