Assistant Regulatory Affairs (m/f)

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Having more than two 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).

Assistant Regulatory Affairs (m/f)

YOUR TASKS AND RESPONSIBLITIES :

Compiling of

  • Quality documentations/CMCs for Clinical Trial Application Dossiers
  • Marketing Authorization Application Dossiers

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:

  • Degree in natural science (Bachelor, Master)
  • 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. 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. Depending on your qualifications and experience, we offer a competitive compensation package. We are obliged by law to state that the minimum salary for this position is EUR 2.350 gross per month.

We are looking forward receiving your application.

piCHEM Forschungs- und Entwicklungs GmbH
Mag. Birgit Schütz
Web: www.pichem.at

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