Senior Specialist Regulatory Affairs
| KANDIDATEN ID 2824.01.k18811 |  |
WEITEREMPFEHLEN
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HEUTIGE FUNKTION |
Senior Specialist Regulatory Affairs | |
AUS-/WEITERBILDUNGEN |
Diverse Aus- und Weiterbildungen im Laufe der beruflichen Tätigkeit. | |
AUSBILDUNG/STUDIUM |
• Postgraduate Master Programme - Regulatory Affairs for Biopharmaceuticals - University of Freiburg
• PhD Thesis - Department Biomedicine - University of Basel (former Institute for Medical Microbiology) • Study of Biology, Biozentrum at the University of Basel |
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GRUND ZUR STELLENSUCHE |
Neue berufliche Herausforderung. | |
STELLENWUNSCH |
Als Regulatory Affairs Manager für Arzneimittel mit den Schwerpunkten Life-Cycle Management, Labeling, Erstellen von CMC-Dokumenten, Schweiz / EU. | |
WUNSCHARBEITSORT |
Grossraum Basel | |
ANSTELLUNGSART |
Festanstellung | |
ARBEITSPENSUM |
80% | |
BERUFSERFAHRUNG UND ERFOLGE |
• Boasting over 15 years of experience in regulatory affairs within the pharmaceutical industry, I specialize in biotechnological and chemical products across various therapeutic areas.
• Proficient in variation filing globally, including in the EU, US, Asia, South America, and national filing in Switzerland, Germany, and Austria. • Skills include compiling CMC documents (Module 3) and updating packaging material (Module 1), with experience in medical device regulation. • Maintenance of authorized pharmaceutical products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations • Evaluation, strategy development and submission of variations using eCTD as well as eDOK format for following applications: - Swissmedic Portal (Switzerland) - PharmNet.Bund (Germany) - BASG eServices (Austria) - Common European Submission Portal (CESP) (EU) |
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STÄRKEN/SCHWÄCHEN |
analytisches Denken und Handeln, strukturiert, belastbar | |
SALÄRWUNSCH |
CHF 135'000 + Bonus VB (80%) | |
VERFÜGBARKEIT |
3 Monate | |
PERSONALBERATER |
Bernwald Personalberatung GmbH, Grabenackerstrasse 11, 4142 Münchenstein Frau Almut Bernwald, +41 61 821 02 02, |
