Specijalista registracija (Banja Luka, BA, 78000)

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.

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