Regulatory Affairs Professional (m/f)

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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Regulatory Affairs Professional (m/f)

(based in Vienna, temporary employment)

Responsibilities:

  • Provide national regulatory affairs expertise on assigned Amgen products
  • Plan and manage local regulatory submissions in compliance with Amgen and national regulatory requirements
  • Review and approve labeling source texts and own country artwork
  • Review promotional material
  • Act as regulatory advisor for local medical and commercial teams
  • Act as regulatory advisor on national laws and regulations for regional and global teams
  • Act as point of contact with regulatory agencies
  • Monitor the external regulatory environment and forwards information to local/regional groups communicating the impact to Amgen
  • Work closely with cross-functional colleagues in the affiliate to align on strategy and deliver affiliate goal
  • Exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations/regulations in a timely manner
  • Partner with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of assigned Amgen molecules
  • Participate in local regulatory process improvements, initiatives and training

Qualifications & Competencies:

  • Master's degree (scientific area, e.g. pharmacy) or bachelor's degree (scientific area) and at least 3 years of directly related experience
  • Knowledge of Regulatory principles
  • General knowledge of national legislation and regulations relating to medicinal products and understanding of drug development
  • Experience in submitting clinical trial applications to the relevant regulatory agencies
  • Experience working with policies, procedures and SOP's
  • Fluency in German and English (both oral and written)
  • Attention to detail.
  • Eager to learn
  • 'Can do' attitude

We offer an annual minimum base pay of EUR 56.000 gross/per year (All-In) and attractive benefits (e.g. flexible working hours, bonus payment, pension plan, lunch allowance …). The final compensation package will depend on your qualification and experience.

We are looking forward to your application. Please apply via our online portal at www.amgen.at/karriere (R-83049)

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