Position Overview: Lead Specialist, Regulatory Affairs is responsible for all RA tasks of own modality with supervision by the direct manager or project leader. Report to direct manager or to project leader or to core-team co-workers about submission projects status when it’s requested. This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.


Key Responsibilities:
・Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.

・Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.

・Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.

・Assesses changes in existing products to and determines the need for new /revise licenses or registrations.

・Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.

・Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

・Contributes to writing and editing technical documents.

・Assesses adverse events through approved license dossier to support Safety Management Team.

・Understands and applies regulatory requirements and their impacts for submissions. (Monitor new/revised requirements and investigate the impact to Japan registration. Triage entry and to be Subject Matter Expert as required.

・Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions (Access to multiple sources to get necessary information with clear objectives and strategies.)

・Ensures compliance with pre- and post-market product approval requirements.  (Lead communication with authorities as necessary and take appropriate action with detailed supervision of direct manager or project leader.)

・Supports regulatory inspections as required. (Support direct manager to have internal and　external audit.)

・Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.