Cmc Globalni Specijalista

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.**Global Regulatory Affairs - Regulatory Global CMC (Chemistry, Manufacturing and Controls) specialist**

**Place of work: Vršac or Belgrade**

**Requirements**:

- Education of chemical, pharmaceutical or technological profession
- Active knowledge of English language (written and spoken) - C1 level
- Advanced level of knowledge of MS Office package
- Minimum 2 year experience on similar roles

**Your duties would include**:

- Responsibility for drafting the regulatory documents of the chemical-pharmaceutical quality part of the drug (Modules 2.3. and 3)
- Preparation of the Study Dossier (IMPD) (dossiers for clinical trial medicinal products), as well as activities related to evaluation / assessment of registration dossiers on a global level
- Defining activities that need to be carried out as a part of the preparation of responses to the Agency's requests during the procedure of new registrations and/or renewals and variations for CMC part of the dossier (Module 3)
- Responsibility for independent planning and implementing the project task and making own decisions related to the project.
- Manages projects, reports and takes responsibility for products.

**What we offer**:

- Private health insurance
- Dynamic work environment
- Continuous education and training
- Possibility of promotion
- Please attach your CV in English.