freiberufler Regulatoy Affairs Executive auf freelance.de

Regulatoy Affairs Executive

offline
  • 50€/Stunde
  • 81243 München
  • Umkreis (bis 200 km)
  • en
  • 12.03.2020

Kurzvorstellung

I currently hold a master’s degree in Pharmaceutics and have two years of experience worked on FDA and EMA eCTD Submissions. Well versed with ICH quality guidelines, eCTD, CTD, SPL formats. I am fully versed in all aspects of FDA and EMA regulations

Qualifikationen

  • CMC
  • CTD
  • EcTD
  • Gute Herstellungspraxis (GMP)
  • ICH Guidelines
  • Labeling
  • Publishing
  • Quality Overall Summary
  • SPL
  • Validation

Zertifikate

Masters Of Pharmacy
2015

Ausbildung

Masters of Pharmacy
Pharmaceutics
2015
India

Über mich

I currently hold a master’s degree in Pharmaceutics and have two years of experience worked on FDA and EMA eCTD Submissions. Well versed with ICH quality guidelines, eCTD, CTD, SPL formats. I am fully versed in all aspects of FDA and EMA regulations and policies regarding all medical products and understand the guidance that is used for these regulations. I can collaborate and interact with many different disciplinary groups to develop and register marketing strategies for any project.
I am able to conduct research for regulatory need and can allocate the affairs along with submitting advertising proposals and any promotions the client requires. In order to do this, I always keep up with the latest trends and merge all new requirements for each department.

Weitere Kenntnisse

Masters of Pharmacy

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
Reisebereitschaft
Umkreis (bis 200 km)
Arbeitserlaubnis
  • Europäische Union
Profilaufrufe
1389
Alter
32
Berufserfahrung
7 Jahre und 6 Monate (seit 09/2016)

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