Regulatory Specialist, Registration Data Management
GSK
Poland - woj. wielkopolskie
17 d. temu

Your Responsibilities :

GSK is deeply committed to professional and personal development offering employment opportunities across a diverse collection of businesses and geographies.

So you’ll flourish in an inspiring environment where personal growth plays a vital part in the changing face of the business.

Most of all, you’ll enjoy the sense of purpose that comes from leading change in an industry that touches millions every day.

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 :

    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
  • When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    Thank you for your interest in this opportunity. The information that you have provided in your cover letter and CV will be used to assess your application.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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