Oferta pracy

Regulatory Affairs Specialist

GSKAbout the company

  • Warszawa

    Warszawa, Masovian
  • Offer expired 24 days ago
  • Remote recruitment
  • contract of employment
  • full-time
  • specialist (Mid / Regular), junior specialist (Junior)

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.

  • Ability to work in a group, ability to work remotely / Ability to work without direct supervision.

  • High own work organization skills, responsibility.

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

Optional

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

  • Relevant experience in Artwork Coordination or Regulatory Affairs.

  • Proofreading skills.

What we offer

  • Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness.

  • 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

Are you looking for a regulatory affairs role that will enhance your documentation knowledge and allow you to help shape systems strategy? If so, this Regulatory Affairs Specialist role could be an exciting opportunity to explore.

Regulatory Affairs Operations Department maintains the organization’s on-going relationships with regulatory commissions/authorities relating to technical issues. Ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints.

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