Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Regulatory Local CMC Specialist

Place of work: Belgrade

About the job:

As a CMC (Chemistry, Manufacturing and Controls) local specialist, you would play a key role in preparing pharmaceutical-chemical documentation for product registration, both on the domestic market and internationally (Western Balkans, Ukraine, Romania, and eurasian markets). Your responsibilities would include coordinating activities related to the preparation of documentation, ensuring its compliance with EU and ICH regulations, as well as securing the necessary materials in collaboration with colleagues from various departments.

Responsibilities:

• Independently preparing pharmaceutical-chemical registration documentation.
• Preparing documentation in accordance with EU and ICH regulations for domestic and international registration purposes.
• Obtaining materials for completing documentation.
• Coordinating activities related to documentation creation.
• Archiving documentation.

Qualifications:

• University degree in pharmacy, medicine, technology or chemistry.
• Preferable previous work experience in similar positions.
• Fluent in English, both in conversation and in writing. 
• Required IT knowledge (MS Office package).

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.

Only shortlisted candidates will be contacted.