#R-208672
and delivering strategic outcomes.
Responsibilities:
Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans
Lead and/or support JAPAC health agency engagements
Lead and/or support JAPAC filing activities and associated health agency inquiries
Support device design controls activities and documentation reviews
Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region
Perform change control regulatory assessments as it relates to JAPAC
Develop and support implementation and maintenance of internal regulatory processes
Perform device determination decisions for regulated items to be developed and/or used in JAPAC region
Support supplier engagement teams and due diligence activities in the JAPAC region
Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region
Support regulatory compliance initiatives in the JAPAC region
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree; or
Master's degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or
Bachelor's degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience
Preferred Qualifications:
Master's degree in regulatory affairs, engineering, or life sciences
6 or more years of experience in medical device regulatory affairs
Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development
Experience in drug delivery device or diagnostics device regulatory submission process
Regulatory CMC specific knowledge and experience
Mature project management and organizational skills
Strong and effective oral and written communication skills
Experience in Veeva Vault platforms
.