Daniela S. Rosa

Daniela S. Rosa Email and Phone Number

Regulatory Operations | Regulatory Affairs @ AbbVie
Daniela S. Rosa's Location
São Paulo, São Paulo, Brazil, Brazil
Daniela S. Rosa's Contact Details

Daniela S. Rosa personal email

n/a
About Daniela S. Rosa

Regulatory Affairs professional with 18 years in the biopharmaceutical/ medical devices industry, experienced with all aspects of regulatory affairs and the product development lifecycle, with strong global/ international perspective and business acumen.

Daniela S. Rosa's Current Company Details
AbbVie

Abbvie

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Regulatory Operations | Regulatory Affairs
Daniela S. Rosa Work Experience Details
  • Abbvie
    Associate Director, Regulatory Information Management
    Abbvie Jul 2021 - Present
    North Chicago, Illinois, Us
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  • Abbvie
    Associate Director, Regulatory Affairs Operations International
    Abbvie May 2020 - Jun 2021
    North Chicago, Illinois, Us
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  • Allergan
    Associate Director, Regulatory Affairs Operations International
    Allergan Aug 2019 - May 2020
    Dublin, Coolock, Ie
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  • Allergan
    Secondment, Global Regulatory Affairs Operations
    Allergan Oct 2019 - Dec 2019
    Dublin, Coolock, Ie
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  • Allergan
    Senior Manager, Regulatory Submissions
    Allergan Apr 2018 - Jul 2019
    Dublin, Coolock, Ie
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  • Allergan
    Manager, Regulatory Submissions
    Allergan May 2015 - Mar 2018
    Dublin, Coolock, Ie
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  • Allergan
    Specialist, Regulatory Affairs
    Allergan Oct 2012 - Apr 2015
    Dublin, Coolock, Ie
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  • Abl - Antibióticos Do Brasil Ltda.
    Regulatory Affairs Coordinator
    Abl - Antibióticos Do Brasil Ltda. May 2012 - Oct 2012
    Coordination of the International, Local Regulatory Affairs and Packaging Development Teams, training of Regulatory Affairs personnel. Elaboration of regulatory strategies and evaluation of documents for import and export projects, in accordance with appropriate regulations.Review of drug product and drug substance dossiers for regulatory compliance, responsible for product lifecycle and regulatory intelligence.Interaction with other departments within the company (Quality Control/ Assurance, Production, Supply Chain, Sales) in order to comply with regulatory commitments of existing marketing authorizations and requirements for submission of new marketing authorizations.Interaction with customers, suppliers and regulatory bodies in Brazil and abroad in Latin America, United States, Canada, Japan, Europe, Middle East and Asia.
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  • Abl - Antibióticos Do Brasil Ltda.
    Regulatory Affairs Sr. Analyst
    Abl - Antibióticos Do Brasil Ltda. Mar 2012 - Apr 2012
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  • Abl - Antibióticos Do Brasil Ltda.
    Regulatory Affairs Analyst
    Abl - Antibióticos Do Brasil Ltda. Sep 2009 - Feb 2012
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  • Abl - Antibióticos Do Brasil Ltda.
    Regulatory Affairs Jr. Analyst
    Abl - Antibióticos Do Brasil Ltda. Feb 2007 - Aug 2009
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  • Abl - Antibióticos Do Brasil Ltda.
    Regulatory Affairs Intern
    Abl - Antibióticos Do Brasil Ltda. Jul 2006 - Jan 2007
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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 Standard Operating Procedure Regulamentos

Daniela S. Rosa Education Details

  • Universidade De São Paulo
    Universidade De São Paulo
    General
  • Usp - Universidade De São Paulo
    Usp - Universidade De São Paulo
    Pharmaceutical Sciences

Frequently Asked Questions about Daniela S. Rosa

What company does Daniela S. Rosa work for?

Daniela S. Rosa works for Abbvie

What is Daniela S. Rosa's role at the current company?

Daniela S. Rosa's current role is Regulatory Operations | Regulatory Affairs.

What is Daniela S. Rosa's email address?

Daniela S. Rosa's email address is da****@****gan.com

What schools did Daniela S. Rosa attend?

Daniela S. Rosa attended Universidade De São Paulo, Usp - Universidade De São Paulo.

What skills is Daniela S. Rosa known for?

Daniela S. Rosa has skills like Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Fda, Pharmacovigilance, Anvisa, Gmp, Change Control, Pharmaceutics, Regulatory Requirements, Technology Transfer, Gxp.

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