Puppala Anitha
Regulatory Affairs Manager at Amgen India
- Role
- Regulatory Affairs Manager at Amgen India
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Puppala Anitha
CMC Regulatory professional with more than 14 years of biotech industry experience inclusive of mAb purification process development (R&D) and CMC Regulatory. CMC regulatory experience includes review of country specific dossiers (EMA/MHRA/Health Canada), responses to queries, conduct change control assessments, and meticulously review CMC documents that support IMPD, MAA and BLA submissions. Downstream mAb purification process development experience of 14 years includes, Scale down model establishment, process characterization, process intermediate hold time establishment resin/membrane reuse studies & viral validation studies. Technology transfer and scale up to Evaluation of New technologies such as inline concentrator (ILC) and single pass TFF (SPTFF) for high concentration mAb formulation. Involved in clinical manufacturing campaign in cGMP 1KL Single Use Technology facility.
Experience
Regulatory Affairs Manager
Feb 2026 — Present · Hyderabad, IN
Education
Sri Venkateswara Institute of Medical Sciences (SVIMS), Tirupati
Master's degree, Master of science in Biotechnology
2006 — 2008
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