REGULATORY AFFAIRS SPECIALIST (F/M/D) 85%
Standort: Vienna, Austria
Art: Teilzeit
Firma: Novartis
Eingetragen am: 2022-11-15
Kontakt:
Beschreibung:
355086BR
Job Description

Regulatory Affairs Specialist (f/m/d), Vienna, Austria

10! highly motivated associates are working within Regulatory Affairs Novartis Pharma ensuring that innovative medicines are delivered to patients. As Regulatory Affairs Specialist (m/f/d) you will closely work with internal and external stakeholders and will be responsible for the compilation and submission of variations and for the end-to-end artwork labeling process.

Your key responsibilities:
  • Manage medium to small level global regulatory submission projects
  • Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products
  • Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products
  • Write, edit and/or manage the production of high-quality clinical documentation for submission to regulatory authorities in support of marketing applications
  • Develop professional expertise, applies company policies & procedures to resolve a variety of issues
  • Represent organization on specific projects
  • Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Refer to established policies & procedures for guidance

     
Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
  • Completed secondary or higher education (HAK/FH)
  • Previous work experience in a similar role
  • Structural working style
  • Team player
  • Ability to work under pressure
  • Open communication style
 

 

Anhang: hier