Regulatory Affairs Specialist

Solliciteer op de website van de werkgever

As a Regulatory Affairs Specialist you have an important role within the company, so you'll be responsible for many things.

 Your tasks will be:

  • Ensure compliance with regulatory agency regulations and interpretations. 
  • Prepare responses to regulatory agencies' questions and other correspondence. 
  • Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines. 
  • Involve with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  • Provide solutions to a variety of problems of moderate scope and complexity. 
  • Organize and maintain reporting schedules for new drug application and investigational new drug applications.
Uren:
40

Over de werkgever

XDES is specialist in recruitment van technisch personeel. 

Wat wij bieden

A great job opportunity at a large healthcare company.

Vaardigheden

  • Experience in dossier development of Module 3 IND/IMPD or MAA/BLA
  • Able to work in a Documentum System
  • Skilled in Word
  • Hands on dossier development experience
  • RA CMC guideline knowledge
  • Good communication Skills
Ervaring

4 jaar

  • Voor deze functie is er geen minimale werkervaring vereist

Opleiding

HBO

Wat wij bieden

Contract:
1
Solliciteer

Solliciteer op de website van de werkgever

Of solliciteer later

XDES

Joost Storms
XDES

Telefoon 023 55 78 529 | E-mail joost@xdes.nl