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Regulatory Intelligence Expert

Város:  Budapest
Szakterület:  Természettudományok, Kutatás
Tapasztalati szint:  3-5 év

Our founder, Gedeon Richter's dream of a successful international pharmaceutical company still lives today. And we take it to the next level every day by discovering new active pharmaceutical ingredients and introducing new medicines that improve the quality of life for many people around the world.

Gedeon Richter is looking for a committed and experienced professional for the position

Regulatory Intelligence Expert

Purpose of role

The Regulatory Intelligence Expert monitors and assesses trends, regulations, guidance, policy, and legislation to ensure its incorporation into the organizational knowledge of stakeholders with the ultimate goal of ensuring quality compliance

Your tasks will be

  • Monitors the regulatory environment (international, national, local), interprets content and shares these changes to targeted Richter stakeholders
  • Provides regulatory assessments of specific requests, with a focus on timeliness, format, content and thus ensuring value-add to key stakeholder
  • Acts as Regulatory Intelligence Liason for one of following regions (European Union & North America, Latin America, Commonwealth of Independent States, Asia Pacific & Rest of World)
  • Notifies regulatory professionals responsible for key development projects or submission activities when regulatory changes occur impacting documentation, ensuring compliance
  • Preparing reports on the latest information obtained
  • Developing professional articles for the RI monthly

You bring to our team

  • MD / PharmD or  degree in life sciences
  • Hands-on Regulatory affairs and/or Pharmacovigilance experience is a must
  • Biotechnology experience/knowledge can be an advantage
  • Excellent written and verbal communication, with good presentation skills
  • Good command of English language 
  • Solution and detail oriented
  • Curiousity for knowledge
  • The ability to interpreting guidelines and legal regulations
  • An experience in Competent Authority work is an advantage

Other information

  • This position is fixed-term (about 2 years)

We offer

  • Extensive benefits package (cafetera, stock program, private life insurance)
  • Training and development opportunities
  • Medical services (Medicover) 
  • Various sport and health opportunities (gym, swimming pool, AYCM)
  • Challenging, responsible professional work
  • Work in an innovative and secure workplace
  • Work in a unique, multi-area research team

The Richter community is looking forward to your application.

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