Regulatory Affairs Associate - secondment/fix-term contract
Core
Assists Regulatory Affairs Management in obtaining and maintaining licenses and applications in accordance with regulatory strategy and company standards.
Role type
Regulatory Affairs Associate (Secondment/fix-term contract)
Builds
Regulatory submissions and license applications for pharmaceutical products
Domain
Biopharmaceutical / Regulatory Affairs
Required skills
Document management, submission planning and execution, Health Authority system interface, regulatory documentation tracking, project management
Preferred skills
Regulatory/medical/technical experience, knowledge of submission and approval processes, knowledge of company business and processes
Technologies
Document management systems, Health Authority portals (FDA, EudraLink)
Responsibilities
Manage regulatory files and systems, prepare and execute simple submissions, interface with Health Authorities, order and track regulatory requirements (samples, certificates, legal docs), provide coaching and mentoring within the team, contribute to process improvement
