Country: Hungary
Functional area: Regulatory Affairs
A rare and exciting opportunity to be part of a global life sciences software solution provider as a Regulatory SME and joining their newly established team in Budapest.
The role will liaise with major pharmaceutical companies and regulagory leaders within Europe.


Responsibilities:
  • Working operationally and strategically with Product owners and customers to understand business requirements
  • In projects, provide regulatory expertise and guidance on procedural and documentation requirements
  • Analyze and synthetize requirements and impact of various scenarios
  • Be the regulatory advisor for Engineering team
  • Track regulatory updates from different Health Authorities and inform thecustomers
  • Provide Trainings and Conduct workshops

Requirements:
  • Strong experience of XEVMPD, IDMP Guidelinesand strong knowledge in EMA and FDA regulations
  • Good understanding of ISO IDMP and EMA Iteration, plus IDMP implementation guidelines
  • Knowledge of RIMs tool or Extensive experience in managing pharmaregulatory compliance products
  • Conducting projects efficiently and proactively
  • Collaborating with multinational project teams
  • Strong knowledge of English both in oral and written
  • Working with cross-functional working groups as needed Functional and ITskills
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.
A rare and exciting opportunity to be part of a global life sciences software solution provider as a Regulatory SME and joining their newly established team in Budapest.
The role will liaise with major pharmaceutical companies and regulagory leaders within Europe.

Responsibilities:

  • Working operationally and strategically with Product owners and customers to understand business requirements 
  • In projects, provide regulatory expertise and guidance on procedural and documentation requirements
  • Analyze  and synthetize  requirements and impact of various scenarios 
  • Be the regulatory advisor for Engineering team
  • Track regulatory updates from different Health Authorities and inform the customers
  • Provide Trainings and Conduct workshops

Requirements:

  • Strong experience of XEVMPD, IDMP Guidelines and strong knowledge in EMA and FDA regulations
  • Good  understanding of ISO IDMP and EMA Iteration, plus IDMP implementation  guidelines
  • Knowledge of RIMs tool or Extensive experience in managing pharma regulatory compliance products
  • Conducting projects efficiently and proactively 
  • Collaborating with multinational project teams 
  • Strong knowledge of English both in oral and written
  • Working with cross-functional working groups as needed Functional and IT skills
 
Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.

Regulatory English