GSK

Regulatory Affairs Associate

3+ months agoBudapest, Hungary

Site Name: Hungary - Budapest
Posted Date: Feb 8 2021
GSK Consumer business is looking for a Regulatory Affairs Associate colleague to join our team in Budapest!

This position has responsibility for Regulatory Affairs in defined portfolios or activity streams within CEE Export Markets.

Responsibilities:

  • Manage preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market.
  • Actively contribute to the activity of a high performing local teams, including looking for ways to improve the performance.
  • Manage compliance within defined portfolio/activity streams in line with GSK Consumer Healthcare expectations - support key processes and ways of working.
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
  • Proactively manage impact of regulatory changes within defined scope of responsibility on the business.
  • Maintain required regulatory compliance databases, systems and processes.
  • Maintain high level of knowledge on the science of products within defined portfolio.
  • Review, correct and approve the artworks; review and approve promotional materials.
  • Support in the maintenance of global and local regulatory trackers and databases.
  • Preparation and submission of faulty pack approvals of medicines to the National Institute of Pharmacy and Nutrition (NIPN).
  • Write and submit correction requests for the newly approved marketing authorizations of medicinal products to National Institute of Pharmacy and Nutrition (NIPN).
Requirements:
  • Masters (MS, MA), or PhD/PharmD/ Qualified Person, Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering).
  • Minimum of 3 years' experience in Regulatory Affairs.
  • Fluent English knowledge.
  • Precise in work.
  • Proactivity, reliability.
  • Good team player.
  • Meeting deadlines and enable to coop with complex tasks.
  • Ability to multi-task and work under pressure.
What we provide:
  • GSK is a " MODERN EMPLOYER ", which provide a supportive working environment, development opportunities and competitive compensation packages designed to attract and to retain the very best.
  • We are proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish.
  • A science-led global healthcare company that researches and develops a broad range of innovative medicines and brands.
  • Our products are used by millions of people around the world, helping them to DO MORE, FEEL BETTER AND LIVE LONGER.
*LI-GSK

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Job ID: glaxo-278897-en-us