Overview

Responsible for the management/strategy of Regulatory Affairs (RA) activities in Japan (supporting all of Abbott Rapid Diagnostics), including Key Opinion Leader (KOL) Advisory Board development and management.

Responsibilities

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 registration of products in alignment with product development and regulatory plans.Actively participates in short and long-range planning including the development of Key Performance Indicators.Manages the budget and resources of 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 organisation, including through organised training programmes.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 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.

Reporting to

Commercial Regulatory Head, Asia PacificGeneral Manager Abbott Rapid Diagnostics Infectious Disease Japan (dotted)

Qualifications

Essential

BSc or equivalent.Training in Regulatory Affairs.Management experience, including relevant experience at a senior level.A minimum of 10 years’ experience in areas directly relevant to the position, ideally within IVD industry.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 toward successful product approvals. 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.

Competencies and Attributes

Ability to develop and manage high performing teams to achieve desired outcomes.Demonstrated capacity to successfully execute strategies designed to achieve an appropriate return on investment for the business.Demonstrable working knowledge of the medical diagnostics industry.Understanding of Quality and Quality Management systems (ISO 13485, ISO 9001)Knowledge of the requirements of industry regulators.Knowledge of the Japan regulatory environment.Capacity to apply sound judgement for the effective management of the company’s resources and personnel.Capacity to identify strategic opportunities and recognise threats.Excellent written and oral communication skills in English and an ability to influence, lead, negotiate and work effectively at all levels.Strong mission orientation.Attention to detail.Strong interpersonal skills, highly collaborative, strong influencing skillsand ability to build effective working relationships.Highest levels of integrity and diplomacy.Capacity to maintain the highest levels of confidentiality internally and externally.