Associate Director, Regulatory Information Management @ (July 2021 - Present)
Associate Director, Regulatory Affairs Operations International @ (May 2020 - June 2021)
Associate Director, Regulatory Affairs Operations International @ (August 2019 - May 2020)
Secondment, Global Regulatory Affairs Operations @ (October 2019 - December 2019)
Senior Manager, Regulatory Submissions @ (April 2018 - July 2019)
Manager, Regulatory Submissions @ (May 2015 - March 2018)
Specialist, Regulatory Affairs @ (October 2012 - April 2015)
Regulatory Affairs Coordinator @ (May 2012 - October 2012)
Regulatory Affairs Sr. Analyst @ (March 2012 - April 2012)
Regulatory Affairs Analyst @ (September 2009 - February 2012)
Regulatory Affairs Jr. Analyst @ (February 2007 - August 2009)
Regulatory Affairs Intern @ (July 2006 - January 2007)
Daniela S. Rosa Education
Universidade de São Paulo
Master of Business Administration (MBA) (Business Administration and Management, General)
2012-2015
USP - Universidade de São Paulo
BS (Pharmaceutical Sciences)
2002-2006
Daniela S. Rosa Skills
Regulatory Affairs
Regulatory Submissions
Pharmaceutical Industry
FDA
Pharmacovigilance
ANVISA
GMP
Change Control
Pharmaceutics
Regulatory Requirements
Technology Transfer
GxP
21 CFR Part 11
V&V
SOP
Pharmaceuticals
Active Pharmaceutical Ingredients
Computer System Validation
eCTD
CEP Application
Regulatory Publishing
Regulatory Information Management
Regulatory Operations
Social Media
Public Speaking
Publishing
Strategic Planning
Customer Service
Project Management
Research
Standard Operating Procedure Sop
Regulamentos
Standard Operating Procedure
Daniela S. Rosa Summary
Daniela S. Rosa, based in State of São Paulo, Brazil, is currently a M16 SPQS - Standing Industry Observer Expert (IFPMA) at International Council for Harmonisation (ICH). Daniela S. Rosa brings experience from previous roles at AbbVie and Allergan. Daniela S. Rosa holds a 2012 - 2015 Master of Business Administration (MBA) in Business Administration and Management, General @ Universidade de São Paulo. With a robust skill set that includes Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, FDA, Pharmacovigilance and more. Daniela S. Rosa has 1 emails on RocketReach.
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