Loading...
 
Share this Job

Regulatory Intelligence Expert

Apply now »

Date: Jan 5, 2022

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

 

Headquartered in Hungary, Gedeon Richter Plc. is an innovation-driven specialty pharmaceutical company. The activities of the Hungarian-directed multinational company are vertically integrated and involve pharmaceutical manufacturing, research and development, sales and marketing. Richter’s goal is to help the public fight off illnesses with innovative products and, by doing so, help improve the quality of human life. 

 

 

About us

Headquartered in Hungary, Gedeon Richter Plc. is an innovation-driven specialty pharmaceutical company. The activities of the Hungarian-directed multinational company are vertically integrated and involve pharmaceutical manufacturing, research and development, sales and marketing. Richter’s goal is to help the public fight off illnesses with innovative products and, by doing so, help improve the quality of human life. 

Organisation

Regulatory Science Strategy and Excellence Unit, part of the Regulatory Science Division 

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 submission activities when regulatory changes occur impacting documentation, ensuring compliance

You bring to our team

  • MD / PharmD or  degree in life sciences
  • Hands-on Regulatory 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

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
  • Long-term employment in an innovative and secure workplace