Regional Regulatory Affairs

5 days ago

Budapest, Budapest, Hungary Carbyne Full time 60,000 - 120,000 per year
Our Global Pharmaceutical company partner operates in 25+ countries and is growing fast. Thanks to the dynamic growth we are looking for a Regulatory Affairs expert to fill the newly created role of Regulatory Affairs and Pharmacovigilance Manager. Are you interested in supervising the RA / PV activities in multiple EPM countries? Are you looking for an environment of rapid change and excitement? Would you like to take part in the construction of the European market? You are the match we are looking for

As RA / PV Manager, your key accountabilities will include:
  • Overall responsibility for regulatory activities in cooperation with corporate functions for products where the company is MAH for partner's products
  • Cooperation and oversight of RA / PV vendors in the countries under the scope of responsibility
  • Establishing regulatory priorities and budgets, PV budgeting
  • Maintaining knowledge of relevant regulations / policies
  • Effective communication with necessary stakeholders, partners, collaboration with CEE and local teams in safety related actions
  • Participating in regulatory audits, ensuring PV inspection readiness at all times
  • Managing PV deviations and CAPAs
Our partner requires the following traits from candidates:
  • University Degree in Life Sciences, Physician or Pharmacist preferable
  • 3-5+ years of prior experience in the principles of RA and PV regulations in the relevant territories (CEE) and global aspects
  • Language skills: fluent Hungarian and English
  • Ability to effectively work in a highly dynamic and changing environment
  • Display of agility
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.

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