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S A.

Regulatory Operations |EU CTR |CTIS |EU Submissions Management |Otsuka Pharmaceuticals|

Maharashtra

5+ years of work experience

Freyr Solutions
Apr 20224 yrs 3 mosPresent

Freyr Solutions
Jun 20211 yr 5 mosOct 2022

Pramuk Healthcare
May 20203 mosJul 2020

Education

Department of Management Sciences (PUMBA), Savitribai Phule Pune University

MBA-Master of Business Administration, Marketing

Department of Management Sciences (PUMBA), Savitribai Phule Pune University

20192 yrs2021

BSc - Bachelor of Science, Biotechnology

Gokhale Edcuation Societys H.P.T.Arts & R.Y.K.Science College, Vidyanagar, Nashik 422005

20163 yrs2019

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S A. on Tal

Headline

Regulatory Operations |EU CTR |CTIS |EU Submissions Management |Otsuka Pharmaceuticals|

About

•EU CTA via CTIS •QC submission documents and structured data •Monitoring of CTIS for Alerts/Notices •Archival of CTA & correspondence •Performing UAT •MPR Publishing | US Region •eCTD Publishing [DLP/SLP/Validation] •Publishing Tools- ISI Tool| Freyr Submit Pro| Pharma Ready| Rosetta eCTD Viewer| Lorenz eValidator etc •FDA applications IND| NDA| ANDA| OTC| BLA| DMF in eCTD

Location

Maharashtra

Work experience

Senior Associate at Freyr Solutions, Apr 2022 - Present · 4 yrs 3 mos

Management Trainee at Freyr Solutions, Jun 2021 - Oct 2022 · 1 yr 5 mos

Marketing Intern at Pramuk Healthcare, May 2020 - Jul 2020 · 3 mos

Education

MBA-Master of Business Administration, Marketing, Department of Management Sciences (PUMBA), Savitribai Phule Pune University

BSc - Bachelor of Science, Biotechnology, Gokhale Edcuation Societys H.P.T.Arts & R.Y.K.Science College, Vidyanagar, Nashik 422005

S A. - Senior Associate in Maharashtra | Tal