Krishna Jogiraju
Senior Manager | RA Publishing & Submissions | Labeling Operations | Global RAPV Operations | Regulatory Affairs & Pharmacovigilance | Astellas Pharma Global Development, Inc.
- Role
- Senior Regulatory Operations Manager at Astellas Pharma
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Krishna Jogiraju
Published Submissions for INDs, NDAs, BLAs, MAA drug applications in eCTD format, also experienced in publishing reports such as CSRs, Preclinical Reports, Safety Reports, Annual Reports and Datasets. Also, involved in the submission of promotional materials to OPDP in eCTD format.* Good sound Knowledge of building complex Regulatory Submissions such as Original IND, NDA, sNDA,BLA, sBLA applications using docuBridge and eCTDXpress.* Involved in Publishing and Submission related activities in association with Global Regulatory Leads to develop Publishing Strategy, for improving Submission ready documents.* Experienced in regression testing and implementation of docuBridge, Veeva Vault RIM.
Experience
Senior Regulatory Operations Manager
Apr 2024 — Present · US
Education
Osmania University
Bachelor's degree, Pharmacy
Western Illinois University
Master's degree, Chemistry
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