Jobs Filtered by

Poland Regulatory Affairs Specialist

  • Location
    (POLAND) and Warsaw
  • Job Reference
    13258
  • Functional Area/Experience
    Business, Accounting & Finance / Fresh Graduate

Job Description & Qualifications

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. 

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.

Requirements:

Obligatory:

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

Nice to have:

  • Experience and familiarity of working within documentation databases and team sites.
  • Relevant experience in Artwork Coordination or Regulatory Affairs.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • 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.


Job Skills/Competencies Required

  • Engagement and motivation, willingness to learn and develop, attention to details.
  • Fluent English and Polish (written and verbal).
  • 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.

Nice to have:

  • Proofreading skills.
Apply now