Amgen Regulatory Affairs Professional (m/f) in Vienna, Austria
For our local Regulatory team, based in Vienna, we are looking for a
Regulatory Affairs Professional with focus on Clinical Trials (m/f)
(temporary employment, preferably full time)
Provide expertise/advise on clinical trials in Austria to local stakeholders
Plan, manage and execute local clinical trial submissions to BASG/AGES in compliance with Amgen and national regulatory requirements
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 and CROs to align on strategy and deliver affiliate goal
Exchange clinical trials focused regulatory information and intelligence with other regulatory team colleagues and cross functional groups on an ongoing basis 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
Experience in submitting clinical trial applications to the relevant regulatory agencies
General knowledge of national legislation and regulations relating to medicinal products and understanding of drug development
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 € 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 .
Please send your application (CV and motivation letter) via our Online tool.
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.