Shruti Arora Email & Phone Number
Associate Director Global Regulatory Affairs @ Roche
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Shruti Arora Location
- Bellevue, WA, US
Shruti Arora Work
- Associate Director Global Regulatory Affairs @ (June 2023 - Present)
- Manager Global Regulatory Affairs @ (March 2022 - May 2023)
- Associate Director Regulatory Affairs @ ROCHE TISSUE DIAGNOSTICS (June 2023 - Present)
- Regulatory Affairs Manager @ ROCHE TISSUE DIAGNOSTICS (March 2022 - Present)
- Staff Regulatory Affairs Specialist @ (December 2021 - March 2022)
- Staff Engineer @ (December 2021 - March 2022)
- Manager (Regulatory Clinical Affairs) @ (January 2020 - December 2021)
- Regulatory Specialist @ (June 2017 - December 2021)
- Regulatory Sr. Specialist @ (June 2017 - December 2019)
- Senior Regulatory Affairs Specialist @ BAUSCH HEALTH (April 2016 - May 2017)
- Regulatory Affairs Sr. Specialist @ (March 2016 - March 2017)
- Team Lead (Pharmacy Manager) @ (June 2015 - February 2016)
- Freelance Consultant @ Pharmaceutical Regulatory Submissions (mainly EU) (May 2013 - May 2015)
- Regulatory Manager @ (June 2011 - June 2013)
- Regulatory CMC Manager II @ (January 2012 - December 2012)
- Regulatory Affairs Specialist 4 (CMC) @ (June 2011 - December 2011)
- Research Scientist (Regulatory Affairs - EU Division) @ (April 2010 - June 2011)
- Research Associate @ (May 2008 - April 2010)
- Regulatory Scientist @ SUN PHARMACEUTICAL INDUSTRIES (May 2008 - June 2011)
Shruti Arora Education
- Punjabi University
M.Pharm/Pharm D (Equivalency established in USA) (Pharmacognosy and Chemistry of Natural products)
2006-2008 - Jamia Hamdard
Bachelor's degree (Pharmacy)
2002-2006 - Cancer research
Pursued internship (Oncology and Cancer Biology)
2015 - Jamia Hamdard
Bachelor of Pharmacy
- Punjabi University
Master of Pharmacy
- Punjabi University
Doctor of Philosophy (Pharmaceutical Sciences)
Shruti Arora Skills
- 21 CFR Part 11
- ANDA
- Analytical Skills
- Biopharmaceuticals
- Biotechnology
- Business Meetings
- CMC
- CRO
- Clinical Development
- Clinical Research
- Clinical Research Auditor
- Clinical Trial Management System (CTMS)
- Clinical Trials
- Companion Diagnostics (CDx)
- Corrective and Preventive Action (CAPA)
- Drug Development
- Drug Discovery
- Electronic Common Technical Document (eCTD)
- FDA
- GCP
- GLP
- GMP
- IND
- Leadership
- Management
- Medical Devices
- Oncology
- Pharmaceutical Industry
- Pharmaceutics
- Pharmacokinetics
- Pharmacology
- Pharmacovigilance
- Precision Medicine
- Quality Assurance
- R&D
- Regulatory Affairs
- Regulatory Agencies
- Regulatory Approvals
- Regulatory Examinations
- Regulatory Intelligence
- Regulatory Requirements
- Regulatory Science
- Regulatory Submissions
- Relationship Building
- Research
- SOP
- SOP'sand Regulatory working procedures
- Standard Operating Procedure (SOP)
- Strategy
- Team Mentoring
- Translational Science
- U.S. Food and Drug Administration (FDA)
- Validation
- eCTD
Shruti Arora Summary
- Shruti Arora, based in Bellevue, WA, US, is currently a Associate Director Global Regulatory Affairs at Roche. Shruti Arora brings experience from previous roles at Roche, ROCHE TISSUE DIAGNOSTICS and BD. Shruti Arora holds a 2006 - 2008 M.Pharm/Pharm D (Equivalency established in USA) in Pharmacognosy and Chemistry of Natural products @ Punjabi University. With a robust skill set that includes 21 CFR Part 11, ANDA, Analytical Skills, Biopharmaceuticals, Biotechnology and more. Shruti Arora has 2 emails and 3 mobile phone numbers on RocketReach.
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