.. Produktentwicklungsteam und enge Zusammenarbeit mit Kollegen aus anderen Fachabteilungen (SPS, CS) Laufende Evaluierung neuer Technologien und deren Integration in unsere Softwareprodukte Sicherstellung der Software-Qualität Mentoring und Coaching von weniger erfahrenen Kolleg:Innen Abgeschlossene Ausbildung .. andere
Regulatory Affairs Specialist (M/F/d)
Having three decades of experience piCHEM is a reliable partner for the manufacturing of synthetic peptides
and peptide related molecules. The company is privately owned and located in Austria. piCHEM provides
peptides and complex organic molecules for medical, biochemical and pharmaceutical research as well as full
GMP service for peptides and peptide conjugates used as active pharmaceutical ingredients (APIs). To
strengthen our team, we are looking for committed and qualified employees for our company location in Raaba
- Grambach.
YOUR TASKS AND RESPONSIBILITIES Compiling of ** Quality documentations/CMCs for Clinical Trial Application Dossier
Marketing Authorization Applications Dossier
Submission procedures to (inter)national authorities
Preparation and performance of submission documents
in accordance with current legislation
Handling of submission portals (e.g. Eudralink, ESG, CESG, CESP, eSubmission Gateway)
Lifecycle management
Post-submission activities: Preparation and submission of response documents to authorities
Compiling of annual reports and amendments
Preparation of variations, PAS, CBEs
Regulatory guidelines and legislation
Up to date knowledge of current (inter)national regulations and guidelines
REQUIREMENTS
Master´s or Bachelor´s degree in natural science
Interest in pharmaceutical aspects and legislation of synthetic peptides and peptide conjugates (APIs/drug
substances) as well as IMPs/drug products in the course of clinical trials and marketing authorization
procedures
Work experience in a regulatory affairs department in a pharmaceutical company preferable
Basic knowledge of (inter)national laws and guidelines (e.g. EU-GMP, AMG, AMBO, ICH, Guidance for
Industry, PIC/S)
Independent, structured, accurate and target-oriented way of working. Assertiveness, reliability and the
ability to deal with deadlines. Capacity for teamwork as well as readiness for new regulatory challenges
Business fluent in English, both written and spoken language. Additional languages preferable
Proficiency in MS Office
This is your opportunity to be part of an organization, working in a dynamic, growing and rapidly evolving
environment to deliver outstanding results that benefit our customers every day.
The gross yearly salary provided for this function is a minimum of EUR 36.000 based on a full-time employment. Any potential overpayment depends on your professional experience and qualifications.
piCHEM Forschungs-und Entwicklungs GmbH , Parkring 3, 8074 Raaba-Grambach, Tel.: +43 316 681711 ,
