In the context of our growing activities, we are looking for a Regulatory Affairs Officer to join our teams in Hungary.

Group 10


  • Develop local Hungarian Regulatory Affairs presence, taking responsibility for new regulatory activities related to Hungary and EU
  • Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services


  • Act as point of contact with local regulatory authorities
  • Responsible for notifying local authorities of appointment
  • Responsible for keeping up to date with local regulatory requirements
  • Support/Contribute to pharmacovigilance (PV) activities performed by the Medical Information & Vigilance Pillar /the Hub in local country
  • Creation and maintenance of local PV system, including creation of a local SOPs and agreements
  • Safety case receipt, translation, tracking and ICSR follow up.
  • ICSR reporting to local regulatory authorities (outside EU)
  • Local literature/journal review
  • Provision or support of medical information services
  • Contribute to the production of client administrative documents, reports and tracking tools
  • Liaise with client, affiliate departments and other 3rd party vendors
  • To comply with client and PLG policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives

Group 11
Education & Experience

  • Bachelor’s degree or more in a Life Sciences related field.
  • At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
  • Previous experience in a consulting company would be a plus

Group 13

Hard/Technical skills:

  • Native Hungarian mandatory along with fluent English
  • Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)
  • Knowledge of Hungary’s regulation for pharmaceuticals (NCE, Biologicals and Biotech) and Medical Devices
  • Strong computer skills, including MS Office applications, data and document management systems (Veeva or comparable EDMS, LorenZ, Trackwise, etc)
  • Experience of promotional/non-promotional activities would be an advantage

Soft skills:

  • Excellent organizational skills
  • Effective oral and written communication skills
  • Ability to work well within a team
  • Process oriented with good attention to detail
  • Ability to prioritize different workloads/multi-task
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on the quality of the work
  • Solution-driven

Regulatory Affairs Officer - 782