Cmc Globalni Specijalista - Bad Vilbel, Deutschland - STADA Arzneimittel AG

STADA Arzneimittel AG

Geprüftes Unternehmen

Bad Vilbel, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 chemicalpharmaceutical 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: