Oferta pracy

Regulatory Affairs Specialist - Specjalista ds. Rejestracji

GSK

  • Warszawa

    Warszawa, Masovian
  • offer expired a month ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • remote recruitment

Your responsibilities

  • Handling matters related to the maintenance of marketing authorizations for medicinal products in Poland.

  • Preparation of registration documentation in a correct manner and in accordance with applicable regulations and company standards.

  • Cooperation with various business structures in order to implement the assumed business tasks and strategies of GSK in Poland.

  • Knowledge and analysis of legal regulations and adapting to requirements.

  • Quality assurance activities for the compliance of the marketed product with the registered data, including verification of artwork and Technical Terms of Supply.

  • Monitoring of available registration data on competitors' activities in accordance with the needs of the commercial part of the company.

Our requirements

  • Engagement and motivation, willingness to learn and develop, attention to details.

  • Fluent English and Polish (written and verbal).

  • Higher education, preferably pharmacy, medicine, biology, biochemistry, chemistry, biotechnology, possibly technical faculties.

  • Computer skills – in the sense of the ease of working on a computer /with systems.

Optional

  • High own work organization skills, responsibility.

  • Experience and familiarity of working within documentation databases and team sites.

  • Relevant experience in Artwork Coordination or Regulatory Affairs.

  • Proofreading skills.

What we offer

  • Career at one of the leading global healthcare companies

  • Contract of employment for approximately 15 months

  • Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

  • Life insurance and pension plan

  • Private medical package with additional preventive healthcare services for employees and their eligible

  • Sports cards (Multisport)

  • Possibilities of development within the role and company’s structure

  • Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

  • Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)

  • Supportive community and integration events

  • Modern office with creative rooms, fresh fruits everyday

  • Free car and bike parking, locker rooms and showers.

  • Benefits

  • retirement pension plan

  • leisure zone

  • extra social benefits

  • holiday funds

  • charity initiatives

  • one shorter working day

  • life Insurance

  • sport and recreation cards

  • annual bonus

  • canteen for employees at site (with discounts)

  • flexible working options available for most positions

GSK

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively

Scroll to the company’s profile