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Regulatory Submissions Coordinator

Regulatory Submissions Coordinator

  • Location

    Germany, Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    benefits package

  • Contact:

    Connor Harknett

  • Contact email:

    Connor.Harknett@volt.eu.com

  • Job ref:

    74008-PHARM-CKT_1555064773

  • Published:

    6 months ago

  • Expiry date:

    2019-04-24

  • Start date:

    May

  • Consultant:

    #

Regulatory Submissions Coordinator - Munich, Germany

Would you like the opportunity to join a major CRO?

I am currently partnering with a global CRO who are projecting to grow by 20% this year and will be looking to increase their Regulatory Affairs department by adding a Regulatory Submissions Coordinator.

You will work on exciting projects across all major therapeutic areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Some of your responsibilities in this role will be:
* Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland
* Prepare and submit responses to queries and amendments to clinical trial applications
* Ensure submissions comply with applicable regulations and guidance documents
* Advise sponsors on changing regulations and compliance requirements
* Track submissions and ensure timely filing of documents
* Collection of essential documents and preparation essential documents packages for drug release.

You will need the following expertise:
* Bachelor's degree in life sciences
* Excellent organisation and communication skills
* Knowledge of Microsoft Office
* Hands-on experience preparing, reviewing, and submitting regulatory documentation
* At least one year of work experience as a Regulatory Submissions Coordinator
* Fluency in English and German language

Package / Benefits:
* Competitive Salary
* Annual Performance Related bonus
* Structured Training
* Career progression
* Flexible Work/Life balance
* Relocation support within region available

If this opportunity is of interest to you then please get in touch!