Impress employers and recruiters.
Choose from hundreds of resume examples.
Impress employers and recruiters.
Choose from hundreds of resume examples.
Tailor your resume to this RA Manager - Abbott Molecular role.
Rezi rewrites your resume against Abbott Laboratories's job description. Free.
Tailor your resume to this RA Manager - Abbott Molecular role.
Rezi rewrites your resume against Abbott Laboratories's job description. Free.
Don't guess if your resume is good enough.
See how it scores against the RA Manager - Abbott Molecular posting at Abbott Laboratories — free, in seconds.
Don't guess if your resume is good enough.
See how it scores against the RA Manager - Abbott Molecular posting at Abbott Laboratories — free, in seconds.
About the Role
The Regulatory Affairs Manager will oversee the regulatory affairs strategy for in-vitro diagnostic (IVD) medical devices and related medical devices in Japan, managing the overall regulatory affairs function to achieve business objectives. This role is responsible for regulatory activities throughout the product lifecycle, from strategy development for new product development and launch, to obtaining approval, formulating and promoting reimbursement and insurance coverage strategies, maintaining approved products, responding to regulations, and handling QMS compliance audits. The position also serves as the primary liaison with PMDA and the Ministry of Health, Labour and Welfare, leading negotiations and authority responses for approval applications, regulatory strategies, and insurance coverage, thereby maximizing product value and improving patient access. Furthermore, by collaborating with global regulatory teams, quality assurance, marketing, and supply chain, this role will drive integrated market introduction plans for approval and reimbursement strategies, contributing to the sustainable growth of the Molecular Diagnostics business. Additionally, the manager will lead the development of a high-performing regulatory affairs organization and its continuous growth through talent development, organizational capability enhancement, and process improvement.
Responsibilities
- Develop and execute regulatory affairs strategies for the Molecular Diagnostics business.
- Formulate regulatory strategies for new product introductions and existing product sales expansion.
- Develop integrated regulatory affairs and market access strategies, considering approval acquisition to insurance coverage.
- Analyze and advise on regulatory risks and opportunities to domestic and international management and business units.
- Support business plans, product portfolios, and launch plans from a regulatory affairs perspective.
- Evaluate business impact and formulate response strategies due to changes in domestic and international regulations and policies.
- Create business opportunities through relationship building with relevant academic societies, industry associations, and administrative bodies.
- Identify and reflect regulatory and market access trends in molecular diagnostics and companion diagnostics in business strategies.
- Oversee new product approval applications, certifications, and notification strategies.
- Negotiate with PMDA and the Ministry of Health, Labour and Welfare as the primary contact.
- Lead responses to PMDA face-to-face consultations, various consultations, and inquiries.
- Manage projects leading to approval acquisition.
- Develop and execute insurance coverage and reimbursement strategies.
- Lead negotiations regarding insurance coverage and medical fees in collaboration with the Ministry of Health, Labour and Welfare, relevant academic societies, and internal departments.
- Develop market introduction plans integrating approval and reimbursement strategies.
- Develop and promote strategies for clinical and analytical evidence required for insurance coverage.
- Negotiate and consult with authorities regarding administrative notices, relevant laws, and regulatory requirements.
- Collaborate on regulatory strategies with pharmaceutical development partners for companion diagnostics.
- Develop regulatory strategies for maintaining approvals and maximizing product value.
- Oversee partial change approval applications, minor change notifications, and other change management activities.
- Conduct regulatory review and approval of electronic package inserts, labeling, IFUs, and promotional materials.
- Develop regulatory strategies for indication expansion, application additions, and new technology introductions.
- Manage regulatory risks throughout the product lifecycle.
- Respond to approval conditions, post-marketing surveillance, and related regulatory requirements.
- Oversee strategies for overseas manufacturer registration and maintenance.
- Oversee responses to QMS compliance audits.
- Strengthen collaboration with the Quality Assurance department and overseas manufacturing sites.
- Ensure alignment with global quality and regulatory requirements.
- Manage and develop the regulatory affairs team.
- Set goals, evaluate performance, and coach team members.
- Promote succession planning and organizational capability enhancement.
- Lead efforts in operational efficiency and continuous improvement.
- Promote collaboration with domestic and international stakeholders.
- Participate as the regulatory affairs representative in key projects.
- Provide strategic support to marketing and sales teams.
- Implement best practices through collaboration with global regulatory organizations.
Requirements
- Bachelor's degree or higher.
- Experience in pharmaceuticals, biology, molecular biology, biochemistry, clinical laboratory science, or related medical technology fields is desirable.
- Over 5 years of regulatory affairs experience in the medical device or in-vitro diagnostic industry.
- Experience leading IVD approval application projects.
- Experience negotiating with PMDA and the Ministry of Health, Labour and Welfare.
- Experience leading cross-functional teams.
- People management experience (3+ years desirable).
- Advanced knowledge of the Pharmaceutical and Medical Device Act (Yakkiho) and related regulations.
- Expertise in IVD and molecular diagnostics.
- Ability to formulate regulatory affairs strategies.
- Excellent project management skills.
- Cross-organizational influence and leadership.
- Problem-solving and decision-making abilities.
- TOEIC score of approximately 700.
- Experience negotiating and presenting with global headquarters.
- Ability to review and create English regulatory documents.
Skills
- Strategic Thinking
- Leadership & People Development
- Business Acumen
- Influencing & Negotiation Skills
- Customer Focus
- Collaboration & Teamwork
- Accountability
- Integrity & Compliance
- Change Leadership
- Continuous Improvement Mindset
Location
- Japan
Work Type
- Full-time
Experience Level
- 5+ years in regulatory affairs
- 3+ years people management desirable
Education Level
- Bachelor's degree or higher
- Degree in Pharmacy, Biology, Molecular Biology, Biochemistry, Clinical Laboratory Science, or related medical technology fields desirable
About the Company
- Molecular Diagnostics business unit.