Company

KCR

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Regulatory Lead (PL)

City/voivodeship

Warsaw

Publication

2019-09-13

Company description

KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.
KCR: We see human behind every number
KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com. 
KCR: We see human behind every number.
Location:  Warsaw, Poland (office-based)
 
The duties associated with the role include:
  • Directly responsible for planning and execution of study level submission strategies across countries
  • Direct responsibility for process definition and compliance with related functional areas
  • Cooperation with Sponsors and internal project teams in the scope of national and multinational trial registration
  • Acting as a main contact point for Sponsors and subcontractors for all aspects related to registration
  • Preparation of documentation for new study applications and amendments. Ensuring good organization of work in the scope of study registration to meet establish deadlines. 
  • Building and maintaining of a strong, collaborative relationship with all stakeholders
  • Accountability for all regulatory aspects of the assigned projects. Ensure that poject work in compleated in accordance with SOPs, policies and practices
  • Serving as a regulatory subject matter expert and supports project management in regulatory related area
  • Maintenance of high level knowledge about EU and non-EU regulations in the area of company interest
  • Participating in preparation and updates of SOPs on regulatory processes
  • Sharing knowledge and experience with functional team
 
Requirements:
  • University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution 
  • Proven experience in Regulatory Lead or Coordinator role at least 2 years
  • Excellent knowledge of GCP including good understanding of regulatory requirements in Poland, ICH guidelines as well as European regulations
  • Ability to work independently and efficiently 
  • Excellent planning, organization and problem-solving abilities
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Open, proactive, committed
  • Fluent command in English 
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry
  • Possibility of getting involved in multinational studies 
  • Onboarding process to enable you fast takeover of duties
  • Peer Buddy Mentor who will introduce you to the organization
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  • Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development 
  • Sport card, healthcare coverage, additional benefits cafeteria, NNW insurance, additional days-off for certain occasions
If you wish to apply, please submit your CV using the button below.