Regulatory Associate





Company description

KCR is a Contract Research Organization (CRO) providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries. The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Late Phase (LP) over a broad range of therapeutic areas. KCR operates across four main regions: North America (NA), Western Europe (WE), Central Europe (CE) and Eastern Europe (EE) with hubs located in Boston, US, Berlin, Germany, Warsaw, Poland and Kiev, Ukraine respectively. The company’s geographical set up suits perfectly to deliver optimized trial execution strategies for life-changing therapies.
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KCR: We see human behind every number.
KCR CRO, a leading Contract Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries, is seeking to employ a Regulatory Associate. The Regulatory Associate shall cooperate on regulatory strategy preparation and be responsible for successful clinical study application submissions to Competent Authorities and Ethics Committees for all assigned countries involved in project, according to Project Management Plan, Standard Operating Procedures, GCP Guidelines and local regulations. The position offers a unique opportunity to cooperate within a team of best in class professionals on an international level.
This is a permanent office-based position in company’s Warsaw Operational Hub.
Location:  Poland (office-based)
The duties associated with the role include:
  • Cooperation with Sponsors, Clinical, Site Contracting and Pharmacovigilance teams, in the scope of a national and multinational trial registration
  • Preparation of documentation for a new study application and updates. Ensuring good organization of work in the scope of study registration to meet established timelines
  • Cooperating on adjustment of application forms and cover letters for submissions in other countries involved in a multinational trial, SOPs updates and preparation
  • Proposing strategy and timelines for initial and subsequent submissions, including safety reporting to Regulatory Authorities and Ethics Committees
  • Tracking amendments to local and European regulations related to study application and updates for the area of investigational medicinal products and medical devices
  • Consulting with the team any challenges in cooperation with local Competent Authority, Ethics Committees and Sponsors
  • Sharing knowledge and experience with functional teams
  • University/college degree in life sciences
  • Minimum of two (2) years of clinical research experience
  • Very good knowledge of GCP, local regulatory requirements, ICH Guidelines
  • In-depth understanding of clinical trial registration process
  • Ability to work efficiently according to local law, EU regulations and guidelines, SOP, ICH GCP
  • Excellent analytical and negotiation skills
  • Fluent command of English
If you wish to apply, please submit your CV using the button below.