Specijalista registracija
Job Description
Company:  Hemofarm Banja Luka d.o.o.
Department:  RAMACA BiH
Job Location (Long): 

Banja Luka|Bosnia and Herzegovina

Country/Region:  Bosnia and Herzegovina
Job Level:  Professionals

SEPARATOR

SHARE THIS JOB

Information at a Glance

Registration Specialist
Location: Banja Luka
Type of contract: Fix termed - Maternity cover

 

About the job:
As a Registration Specialist, you will work on the registration of new and existing pharmaceutical products in accordance with EU and ICH guidelines.

Responsibilities:

  • Independently prepare registration dossiers for new products, as well as documentation for renewals and variations of existing registrations, in line with current EU and ICH guidelines.
  • Collect the necessary documentation and materials for dossier completion in cooperation with colleagues from other organisational units.
  • Ensure the quality and efficient coordination of all activities within the registration process, in accordance with defined work plans and timelines.
  • Archive registration documentation by product in an appropriate and compliant manner.
  • Initiate packaging creation and MOCs, depending on process requirements.

 

Qualifications:

  • University degree in Pharmacy, Medicine or Technology.
  • Previous experience in pharmaceutical regulatory affairs is desirable.
  • Responsibility, proactivity and strong orientation towards teamwork.

 

We offer:

  • Private healthcare insurance (with the option of privileged usage for family members) 
  • Ongoing professional development through specialized education and training
  • A platform for learning 14 foreign languages, using various learning styles, including conversation courses
  • Personalized mental health and well-being support for employees and their families through the Kyan Health app
  • New year bonus 

Only shortlisted candidates will be contacted.