Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Post : Regulatory Affairs Associate
Job Description
• To prepare applications to Markeitng authorrization and clincial trial. Support team for preparation of dossier for timely submissions to the regulatory authorities
• Compile clinical trial applications, Import & export license submission, approval and maintenance for clinical trials per local regulations, ensuring timely submissions, follow-up with and approval from the regulatory authorities
• Respond to regulatory queries seeking support and feedback from appropriate functions within Amgen
• To prepare applications to Markeitng authorrization and clincial trial. Support team for preparation of dossier for timely submissions to the regulatory authorities
• Compile clinical trial applications, Import & export license submission, approval and maintenance for clinical trials per local regulations, ensuring timely submissions, follow-up with and approval from the regulatory authorities
• Respond to regulatory queries seeking support and feedback from appropriate functions within Amgen
