・Is a key member of the local management team
・Develops long and short-term planning of regulatory projects for Japan in collaboration with manufacturing sites and marketing
・Develops strategies to ensure effective achievement of regulatory/business objectives
・Ensures execution of clinical trials and registrations of products in alignment with product development and regulatory plans
・Develops, maintains and directly oversees the KOL program (KOL Advisory Board) in alignment with the commercialization strategy. This will include:
Creation of a road map for KOL development and management
Identification of the appropriate leaders and development of key relationships
Management and coordination of KOL platform contracting, compliance, program scheduling, and verification of speaker/consultant activity
Ensure alignment on strategy and implementation of KOL programs
・Actively participates in short and long-range planning including the development of KPI
・Manages the budget and resources of the scientific support and regulatory activities to ensure fulfilment of the goals of the company
・Leads the development and execution of the reimbursement strategy, including communication with and submission of reimbursement application to Japan Regulatory Agencies
・Promotes awareness of regulatory and customer requirements throughout the organization, including through organized training programs
・Supports sites in contact with Japan Regulatory Agencies
・Represents Japan as RA SME at relevant leadership meetings
・Represents Japan as RA SME in relevant Industry forums
・Supports business operations in product modification reporting
・Facilitates gathering of regulatory intelligence
・Attract, develop and retain a high performing scientific support and regulatory organization while developing a strong talent and leadership pipeline capable of delivering regulatory success in a changing market environment
・Upholds the company’s core values
・BSc or equivalent.
・Training in Regulatory Affairs.
・Management experience, including relevant experience at a senior level.
・In depth experience, leading regulatory strategy and execution of new product launches to Japan market.
・Must be skilled in relationship building and management, demonstrating superior leadership and coaching skills.
・Must have experience participating in multiple regulatory submissions and in leading clinical project teams toward successful product approvals. Must have knowledge of clinical trial methodology and the broader functions associated with clinical trial conduct.
・Experience engaging and maintaining KOL relationships preferred
・Must have effective negotiation skills.