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 Pacific
• General 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.