Sr. Associate, Promotional Regulatory Affairs Specialist, ASIA (Japanese Speaker)
Core
Ensuring compliance of promotional and advertising materials with global, regional, and local regulatory requirements for life sciences products.
Role type
Senior Individual Contributor Regulatory Affairs Specialist (Promotional/Advertising)
Builds
Compliant promotional campaigns, advertising content, and communication strategies for medical devices and pharmaceuticals.
Domain
Life Sciences (Medical Devices, Pharmaceuticals, Ophthalmology)
Required skills
Regulatory review and approval process management, Risk assessment and regulatory interpretation, Policy and procedure development, Compliance investigation, Document management, GxP knowledge
Preferred skills
Medical device/pharmaceutical industry experience, Knowledge of global/local promotional regulations, Cross-functional stakeholder management
Technologies
GxP, SOPs, Quality Management Systems
Responsibilities
Review and approve promotional materials for regulatory compliance, Interpret regulations and guidance documents, Conduct independent regulatory research, Support audits and inspections, Develop compliance policies and training programs, Mentor team members
Seniority
Senior, hands-on IC