Regulatory associate

19/03/20

Location

Steenweg Deinze 150 Nazareth Belgium

Function type

Office based

Vacancy

INTRODUCTION

Akcelis has recently been acquired by Pivotal. Pivotal is a leading therapeutically focused European CRO (Contract Research Organization) focused on helping healthcare clients find unparalleled insights and better solutions for patients.

 

FUNCTION DESCRIPTION

Your typical responsibilities might include:

  • Prepare and submit Competent Authority (CA) and Ethics Committees (ECs) packages to request clinical trial authorizations in Belgium, Netherlands, Luxemburg, and possibily other European countries. Those activites  involve:

    • Ensuring the documentation submitted to ECs and CA is in compliance with applicable regulations;

    • QC translation of documents translated from English to the appropriate language, where required;

    • Translation of EC and CA queries from the local language to English, where applicable;

    • Collection of essential documents necessary for ECs approval from each selected site;

    • Preparation of ECs and CA answers to queries;

    • Submission of answers to ECs and CA queries, if applicable;

  • Participating in regular meetings with the local study teams and the Sponsor, where required.

  • Contract and budget negotiation with sites as needed;

  • Any other activity needed to obtain the required approvals for study start-up and site activitationin the concerned country/ies;

  • Any other regulatory activity needed for the conduct of a clinical study.

     

Ensure working procedures are performed in accordance with Pivotal and/or Sponsors´ SOPs, GCPs and national/international regulations.

 

LOCATION

Our office is located near Ghent, in Belgium

 

PROFILE

  • University Degree in life sciences area is desirable, not mandatory

  • Experience in clinical research at a CRO or a Pharmaceutical Company, as RA is desirable.

  • Sound knowledge of GCPs/ICH and international/local Regulations.

  • Updated knowledge of national/international regulations relative to Clinical Trial Start-Up procedures.

  • Organizational and planning skills.

  • High level of spoken and written English and other languages if required.

  • Good knowledge of current PC-applications.

  • Highly committed and ability to work under pressure.

  • Good communications skills.

  • Empathy and ability to establish good relationships with others.

 

OFFER

  • An attractive salary in line with your experience

  • An in-depth insight into all moving parts of a growing company and professional development.

  • A job in a dynamic company with many challenges

  • Our company is growing and you can grow with us

  • No traffic jams, our office is based in Nazareth (near Ghent)

 

INTERESTED?

Please send your CV to nniclaus@akcelis.com

 

ABOUT PIVOTAL

Since foundation 18 years ago, Pivotal has been widely recognized as an EU-CRO with a solid internal medical franchise, that could act as “co-thinkers” for our clients (and not merely as “doers”), providing as well strategic advice in the complex clinical trials-landscape. Over the years, Pivotal has become an almost 200-strong boutique EU CRO (with >92% of employees are proper) and is legally incorporated in 12 countries across Europe, although can cover many more countries within EU – and has capacity to reach other regions worldwide via partnership with other similar trustful local CROs.

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