Junior Compliance Specialist CEE+

Posted 4 Days Ago
Be an Early Applicant
Hiring Remotely in Budapest, HUN
In-Office or Remote
Junior
Biotech • Pharmaceutical
The Role
Support regional compliance activities across CEE and partner markets, including monitoring, CAPA management, transfer-of-value reporting, FMV updates, data privacy notice preparation, compliance trainings, and system super-user tasks (Veeva, SOOS). Provide operational support to Compliance leadership.
Summary Generated by Built In
Company Description

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

  • Collaborative and team-oriented environment
  • Making a positive impact to help patients
  • Opportunities for professional growth
  • Emphasis on work/life balance
  • Competitive compensation for your work
  • Diversity and Inclusion

Job Description

The Junior Compliance specialist CEE+ (CEE countries: Bulgaria, Croatia, Chechia, Hungary, Poland, Romania, Slovakia, Slovenia and partner markets (Israel, relevant counties in the Balkan and CIS) will support the increasing scope and complexity of compliance activities driven by upcoming launches, expanding teams, and growing business operations.
 

Key responsibilities:

  • Support monitoring activities (data collection)
  • Support monitoring CAPAs
  • Support transfer of value reporting
  • Manage annual FMV updates
  • Preparation, communication and monitoring of Data Privacy Notice (DPN) 
  • Support compliance trainings (systems)
  • Support with systems by being a super user (e.g. Veeva, SOOS)
  • Supporting Compliance Director and Senior Compliance Manager with various tasks

Qualifications

  • 2-3 years of experience in compliance
  • 2-3 years of pharma business experience
  • Located in one of the CEE countries
  • Good knowledge of regional and local Code of Practices as well as key regulations relating to broader aspects of compliance
  • Working knowledge of the healthcare systems in CEE country/ies
  • Proven track record of having undertaken compliance roles within the pharmaceutical industry
  • Business partnering capabilities
  • Strong analytical skills
  • Excellent written and verbal English skills
  • Detailed oriented, good communicator, flexible, self-assured individual
  • Interest in IT tools and trainings

 

Skills Required

  • 2-3 years of experience in compliance
  • 2-3 years of pharmaceutical business experience
  • Located in one of the CEE countries
  • Good knowledge of regional and local Codes of Practice and relevant compliance regulations
  • Working knowledge of healthcare systems in CEE countries
  • Proven track record in compliance roles within the pharmaceutical industry
  • Business partnering capabilities
  • Strong analytical skills
  • Excellent written and verbal English skills
  • Detail oriented, good communicator, flexible, self-assured
  • Interest in IT tools and trainings; ability to act as system super-user (e.g., Veeva, SOOS)
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The Company
2,000 Employees
Year Founded: 2010

What We Do

Sobi is an international biopharmaceutical company dedicated to transforming the lives of people living with rare diseases. Focused on haematology, immunology, and specialty care, the company develops and delivers innovative therapies and breakthrough medicines to patients globally. They aim to improve the lives of those with rare and debilitating diseases through scientific innovation and extensive patient support networks.

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