Regulatory Affairs Specialist

**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
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