Company

KCR

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Regulatory Lead/Manager (PL or UA)

City/voivodeship

Warsaw (woj. mazowieckie)
Kiev (woj. zagranica)

Publication

2018-02-12

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.
For more information, visit www.kcrcro.com.
KCR: We see human behind every number.

 

Location: Warsaw (office-based), Kiev (office-based)
The duties associated with the role include:
  
  • Cooperating with Sponsors and study team, including Project Manager and Legal Department, operational and contracting team in the scope of a national and multinational trial registration
  • Maintaining good relationships with Sponsors, Competent Authorities and partner CRO
  • Providing strategy and timelines for initial and subsequent submissions, estimating risks, proposing and implementing management plan for any arising problems
  • Preparing and/or verifying regulatory documentation for new study application and amendments
  • Keeping track of submission schedule, deadlines and relevant changes in the projects; ensuring good organization of work to meet established timelines
  • Maintaining regulatory files and trackers in assigned projects and being involved in development of new regulatory tools
  • Maintening of high level knowledge about EU and non-EU regulations in the area of company interest (including FDA IND requirements)
  • Participating in Kick-off meetings, audits and other project related meetings according to the company / client needs
  • Sharing regulatory knowledge and experience
Requirements:
 
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing certification, medical or laboratory technology)
  • Minimum of three (3) years experience in submissions of clinical trials
  • Very good knowledge of GCP, local regulatory requirements, ICH Guidelines, European Directives
  • Very good understanding of clinical trial registration process in EU/non-EU countries
  • Ability to work independently and efficiently according to local regulations, SOP, ICH GCP, EU Directives
  • Good planning, organization and problem solving abilities
  • Good communication and interpersonal skills, strong intercultural awareness of international requirements
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in English and/or Ukrainian
 

If you wish to apply, please submit your CV using the button below.