Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this RA Manager - Abbott Molecular role.

Rezi rewrites your resume against Abbott's job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the RA Manager - Abbott Molecular posting at Abbott — free, in seconds.

About the Role

The Regulatory Affairs Manager is responsible for overseeing the regulatory affairs strategy for in-vitro diagnostic (IVD) products and related medical devices in Japan. This role manages the entire regulatory affairs function to achieve business objectives, covering the product lifecycle from strategy development for new products to post-approval maintenance and QMS compliance.

Responsibilities

Develop and execute regulatory affairs strategies for the Molecular Diagnostics Division.
Formulate regulatory strategies for new product introductions and existing product expansion.
Develop integrated regulatory affairs and market access strategies, considering approval and reimbursement.
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 perspective.
Assess business impact and develop response plans for changes in domestic and international regulations and policies.
Build relationships with academic societies, industry associations, and administrative bodies to create business opportunities.
Monitor regulatory and market access trends in molecular diagnostics and companion diagnostics, and reflect them in business strategies.
Oversee regulatory submission, certification, and notification strategies for new products.
Serve as the primary liaison with PMDA and the Ministry of Health, Labour and Welfare for negotiations.
Lead consultations, advice sessions, and responses to inquiries with PMDA.
Manage projects leading to approval acquisition.
Develop and execute reimbursement and insurance coverage strategies.
Lead negotiations regarding insurance coverage and medical fees in collaboration with the Ministry of Health, Labour and Welfare, academic societies, and internal departments.
Develop market launch plans integrating approval and reimbursement strategies.
Develop and promote clinical and analytical evidence strategies necessary for insurance coverage.
Engage in consultations and negotiations 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 regulatory change management activities, including variations, minor change notifications, and other modifications.
Conduct regulatory review and approval of electronic package inserts, labeling, IFUs, and promotional materials.
Develop regulatory strategies for expanded indications, additional applications, and new technology introductions.
Manage regulatory risks throughout the product lifecycle.
Ensure compliance with approval conditions, post-marketing requirements, and related regulatory obligations.
Oversee strategies for overseas manufacturer registration and maintenance.
Manage compliance with QMS conformity assessments.
Strengthen collaboration with Quality Assurance departments and overseas manufacturing sites.
Ensure alignment with global quality and regulatory requirements.
Manage and develop the regulatory affairs team.
Set goals, conduct performance evaluations, and provide coaching to team members.
Promote succession planning and enhance organizational capabilities.
Lead efforts in operational efficiency and continuous improvement.
Promote collaboration with domestic and international stakeholders.
Participate as the regulatory 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 pharmacy, biology, molecular biology, biochemistry, clinical laboratory science, or 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 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.
Regulatory affairs strategy development capabilities.
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 the 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 > Tokyo : Mita South Tower, Minato-ku

Work Type

Standard

Experience Level

5+ years regulatory affairs experience
3+ years people management experience desirable

Education Level

Bachelor's degree or higher
Degree in Pharmacy, Biology, Molecular Biology, Biochemistry, Clinical Laboratory Science, or Medical Technology fields desirable

About the Company

The Molecular Diagnostics division focuses on AMD Molecular.