Junior Regulatory Specialist, Registration Data Management
Stiefel Laboratories, Inc
woj. wielkopolskie, Poland
35 d. temu

Your Responsibilities :

R&D is at the heart of our business.The Regulatory affairs team ensures that all our new drugs meet the most rigorous standards set by the regulatory bodies across the world.

We collect, collate and evaluate scientific data which confirms the quality, safety and efficacy of our medicines all while keeping track of changing global health authority requirements.

These standards must be met as part of the registration processes for clinical trials and marketing approvals across the world.

Join us, and you’ll get the chance to work with other functions across the business, offering guidance and scientific expertise wherever you can.

Responsibilities :

  • ensure that GSK product registration information is maintained to a standard appropriate to support critical regulated processes
  • providing support for regulatory delivery activities (e.g., Annual Reports, DSURs, Variations) of assigned projects
  • producing appropriate components for global regulatory dossiers
  • close cooperation with other departments
  • updating databases
  • Basic qualifications :

  • Bachelor’s or Master’s degree
  • Very good computer skills (work experience with complex computer systems or databases would be an advantage)
  • Fluent Polish and English (both written and spoken)
  • Orientation to details, preciseness
  • Service orientation, customer-focused
  • Ability to work carefully under time constraints
  • Team player attitude
  • Preferred qualifications :

    See Basic Qualifications.

    Why GSK? : We offer :

    We offer :

  • Established job in one of the leading global healthcare companies.
  • Access to newest technologies and solutions
  • Possibilities of development witihin the role and company’s structure
  • Non-wage benefits (private medical healthcare, life insurance, sports card)
  • Free parking area and company canteen
  • Work culture based on respect, honesty, transparency and focus on patient / consumer’s needs
  • Thank you very much for your interest in development opportunities with GlaxoSmithKline

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