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Regulatory Affairs Associate

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Regulatory Affairs Associate

  • Location

    Brussels, Belgium

  • Sector:

    Cloud

  • Job type:

    Contract

  • Salary::

    €40 - €45 per hour

  • Contact:

    Sheridan Williams

  • Contact email:

    sheridan.williams@claremontconsulting.com

  • High Salary:

    45

  • Low Salary:

    40

  • Reference:

    BBBH16165_1554997925

  • Job Published:

    3 months ago

  • Duration:

    12 Months

  • Expiry Date:

    2019-05-11

  • Startdate:

    ASAP

My client a global pharmaceutical organisation is seeking a Regulatory Affairs Associate to join their team.

As the Regulatory Affairs Associate you will be responsible for developing a global regulatory project plans, including a detailed list of submission deliverables, dependencies, approval timing and cost. You will also be Compile regulatory documentation in support of medical device and drug submissions in accordance with local regulatory requirements.


Key skills and experience

-Detailed experience with Regulatory affairs.
-Create / maintain overall schedule for global registration activities and communicate accomplishments and risks to global project team.
-Prepare / update product labeling (i.e., create red-lines, route documents through review / approval process).
-Previous experience supporting global Pharmaceutical registrations; medical device global regulatory experience is advantageous.
- Ability to identify risks and escalate when necessary
-Technical system skills (e.g. word processing, spreadsheets, Microsoft Project, databases, online research, SharePoint)