Company

KCR

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Regulatory Lead (PL)

City/voivodeship

Warsaw

Publication

2018-02-12

Company description

KCR is a contract research organization 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 Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number

A leading Contract Research Organization (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Regulatory Lead. This is a permament position in one of the company's Operational Hubs in Warsaw (PL).The role remains responsible for timely delivery and successful clinical study application submissions and updates.

Location: Warsaw (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, internal PM/CRA/CTDA in the scope of national and multinational trial registration: preparation of documentation for new study application and updates. Ensures good organization of work in the scope study registration to meet established timelines
  • Acting as a main contact point for Sponsors and subcontractors for all aspects related to registration;
  • Mitigates risks by informing Sponsors of all aspects and consequences of missing documentation and timelines
  • Builds and maintains a strong, collaborative relationship with all key stakeholders
  • Serves as regional lead accountable for all regulatory aspects of the assigned projects. Ensures that all project work is completed in accordance with SOPs, policies and practices
  • Serves 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 (including FDA IND requirements)
Requirements:
  • University/college degree (life science or medical degree preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology), or relevant work experience
  • Minimum of four (4) years of clinical regulatory experience 
  • Excellent knowledge of GCP including good understanding of regulatory requirements in Germany as well as several EEA countries (FDA regulations are to be considered as more than welcome)
  • Ability to work independently and efficiently according to sponsor’s expectations, study related SOPs,
  • Excellent planning, organization and problem-solving abilities
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in local office language and in English, both written and verbal
  
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: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.