Aurigene is a specialized biotech company, focused on oncology and inflammatory diseases. Aurigene has deep target and therapeutic area expertise, gained from the experience of multiple programs reaching global clinical development from its efforts. Aurigene has pioneered a unique, collaborative business model to work with pharma and biotech partners, in a win-win partnership that combines Aurigene’s deep expertise in oncology and inflammation, with our collaboration partners’ needs for expertise, scalability and high-quality, quick and cost-effective prosecution of targets.
Group Leader, Regulatory Affairs
with 10+ years of experience in Regulatory Affairs with respect to IND enabling CMC activities along with critical understanding of relevant regulatory requirements for DS & DP across various stages of drug development, scale-up, marketing authorization and commercialization.
Assistant Manager QA - GMP Operations, with 8+ years of experience who shall spearhead quality and compliance requirements pertaining to scale up facility. Good knowledge of GMP standards, review Batch Process Records (BPR), Batch Manufacturing Records (BMRs) and electronic review of data from HPLC, and LC-MS/MS, OOS (Out of specification) and OOT (Out of trend) is mandatory.
Additional Information:
Qualification: Masters degree/PhD in science
Experience: 10+ years
Location: Bangalore
Interested employees may send their updated resumes to apoorva_s@aurigene.com
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