Nancy Kathlen

Angestellt, Director, Global Regulatory Affairs, MakroCare - Drug Development and Commercialization Partner

Newark, Vereinigte Staaten

Fähigkeiten und Kenntnisse

Regulatory Submisssions
Regulatory Affairs
FDA
eCTD
Pharmaceuticals
Pharmacovigilance
Clinical Research
Clinical Trial Management
Regulatory Compliance
Regulatory Requirements
Regulatory Consulting
Clinical Development
Quality Audits
Regulatory Documentation
Process Validation

Werdegang

Berufserfahrung von Nancy Kathlen

  • Bis heute 14 Jahre und 6 Monate, seit Jan. 2010

    Director, Global Regulatory Affairs

    MakroCare - Drug Development and Commercialization Partner

    >Preparing regulatory strategies in order to get approval from regulatory authorities. >Review and provide input into submission documents to ensure quality and accurate support of the regional and global regulatory strategy >Assisting internal and external team in preparation of dossier >Providing correct input to regulatory team to get timely approvals

Sprachen

  • Englisch

    Muttersprache

  • Japanisch

    Gut

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