Japan Regulatory Strategy Manager Job at Amgen (Tokyo)

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
Communication skills in English (TOEIC score ≥860 desirable)
Native level Japanese
Computers: Microsoft Outlook, Word, Excel, Power Point, and communication tools
Ability to develop and lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy
Analytical skills to evaluate and interpret complex situations and problems
Ability to anticipate and prevent potential problems
Ability to independently develop solutions that are thorough, practical, and consistent with functional objectives

Job Responsibility

Develops and implements the Japan regulatory strategy
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy
Consistently look for opportunities to accelerate the developments/approval
Contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads or oversees the preparation of regulatory submissions
Ensures that regulatory submissions are made on time and meet requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies
Ensures that local labels are developed and maintained
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks

Fulltime

Japan Regulatory Strategy Manager

Japan Regulatory Affairs provides leadership, expertise, and execution for the r...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s degree and 10+ years of directly related experience including 5+ years of experience in Regulatory Affairs
In-depth regulatory experience
Knowledge of Japan legislation and regulations relating to medicinal products
Knowledge of drug development Scientific/Technical Excellence
Teamwork
Communication skills both oral and written
Ability to understand and communicate scientific/clinical information
Ability to lead effective teams
Ability to work in matrix environments including cross-functional and global teams
Ability to work under minimal direction with a medium degree of autonomy

Job Responsibility

Develops and implements the Japan regulatory strategy, aligned with global regulatory strategy as much as possible
Provides guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influence developing the global regulatory strategy so that Japan developments are aligned
Consistently look for opportunities to accelerate the developments/approval and/or increase the value of the program to serve for more patients
As a representative of the Japan Regulatory Strategy Group, contributes to the filing plan by advising and discussing with the local and global cross-functional teams
Leads the preparation of regulatory submissions, which may include New Drug Applications (NDAs), briefing documents for various types of PMDA consultations, Clinical Trial Notifications (CTNs), and Orphan Drug Applications in Japan according to the filing plan
Ensures that regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
Collaborates with Clinical Study Operations teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
Ensures that local labels are developed and maintained in line with local regulations and Amgen standards and procedures
Proactively lead to develop regulatory strategies and/or mitigate regulatory risks across RA Japan and/or across Amgen

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Manager, Japan Regulatory Affairs Strategy

Lead strategic regulatory initiatives and grow your career with a global leader ...

Location

Japan , Tokyo

Salary:

7000000.00 - 13800000.00 JPY / Year

Randstad

Expiration Date

July 29, 2026

Requirements

Minimum of 8 years of experience in regulatory affairs within the pharmaceutical industry in Japan
Extensive knowledge of Japanese pharmaceutical regulations and guidelines
Proven experience in leading regulatory strategies and submissions
Excellent communication and collaboration skills
Strong problem-solving and decision-making abilities
Business level or higher proficiency in both Japanese and English
Experience with regulatory affairs for medical devices is preferred
Bachelor's degree in a relevant scientific field is required
Advanced degree (Master's or PhD) is a plus
Experience working with global regulatory teams is a plus

Job Responsibility

Lead the development and implementation of regulatory strategies for pharmaceutical devices
Manage regulatory submissions and approvals for new and existing products
Ensure compliance with all relevant Japanese regulatory requirements
Collaborate with cross-functional teams to ensure timely product launches
Build and maintain strong relationships with regulatory authorities

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

Fulltime

Head of Japan Regulatory Strategy for Oncology and Rare Disease

Facilitate patient access to Amgen products in Japan through executing on our fi...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 11 years of directly related experience including 6+ years of experience in Regulatory Affairs
OR Master’s degree and 13 years of directly related experience including 8+ years of experience in Regulatory Affairs
OR Bachelor’s degree and 15 years of directly related experience including 10+ years of experience in Regulatory Affairs
AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience working with PMDA/MHLW, CROs, and/or contractors
Ability to lead teams
Strong communication skills - both oral and written in Japanese and in English (TOEIC score ≥860 desirable)
Ability to understand and communicate scientific/clinical information
Understanding of regulatory activities and how they affect projects and processes
Ability to set organizational direction & champion change and continuous improvement

Job Responsibility

Provides local input to developing and executing regulatory strategies and effective key regulatory agency interactions
Ensures local labels are developed and maintained in line with local legislation and Amgen standards and procedures
Supervisory oversight for multiple regulatory staff
Be a key point of contact for Japan Regulatory
Senior contact point for regulatory advice for commercial and medical projects for Japan
Translates global and international business plans to local regulatory
Represents Regulatory on Japan affiliate
Contributes to and execute filing plan for Japan
Develops local expertise to evaluate and achieve regulatory success based on proposed strategies
Supports the monitoring, auditing and self-assessment activities under the compliance framework

Fulltime

Regulatory Counsel

Our dynamic APAC Regulatory team is looking for a Regulatory Counsel who has exp...

Location

Japan , Tokyo

Salary:

Not provided

Adyen

Expiration Date

Until further notice

Requirements

Qualified as a lawyer
Strong written and oral communication and interpersonal skills
Strong research, statutory interpretation and organisation skills
At least 3-5 years+ post qualification experience in a regulatory/policy/legal role
Some working knowledge of the payment industry, retail banking, acquiring and finance
Critical thinker, strategic and have innovative problem-solving skills
Strong sense of initiative, independence and ability to take ownership

Job Responsibility

Monitor regulatory developments in legislative and policy environment and advise on its impact to Adyen
Represent the team on a variety of workstreams and drive the regulatory strategy
Operationalise regulatory requirements in Japan for Adyen
Collaborate and provide advice and support to internal stakeholders on legal and regulatory matters in Japan ranging from regulatory engagement, regulatory strategy and product launches
Manage various routine and ad hoc regulatory requests and filings
Advise on various matters with merchants, service providers, internal and external stakeholders, in line with Adyen’s commercial and strategic objectives which allow for scale

Public Policy Manager, Japan

Meta is seeking an experienced Public Policy Manager to contribute to Meta's pol...

Location

Japan , Tokyo

Salary:

Not provided

Security Solutions Product Lead, JP and KR

As the Security Solutions Product Lead for Japan and Korea, you will be responsi...

Location

Japan , Tokyo

Salary:

Not provided

Mastercard

Expiration Date

Until further notice

Requirements

7+ years of experience in product management
Strong understanding of security frameworks and customer challenges in this space in context of payments industry
Proven experience in GTM strategy, pricing, and customer engagement
Familiarity with Japan and Korea regulatory and fraud landscape
Excellent communication, stakeholder management, and analytical skills
Bachelor’s degree in technology, Business, or related field
MBA is a plus

Job Responsibility

Product SME, supporting business development in customer engagements and RFPs to drive revenue
Identify market needs, validate product concepts with customers, and build business cases for new solutions
Define and manage pricing strategies, billing models, and product lifecycle (including sunsetting and rationalization)
Monitor product performance and fraud trends, delivering insights through QBRs and to Sales/Account teams
Drive adoption and retention by partnering with Customer Success, Technical Account managers and delivery teams
Develop and execute GTM strategies including bundling, pricing for new solutions, and embedding SSO in broader platforms
Evaluate product-market fit and maintain feedback loops with global/AP teams to inform roadmap and enhancements
Represent the organization in industry forums and contribute to thought leadership through global insights
Build strategic partnerships to scale SSO offerings and co-create value propositions with key partners

What we offer

Competitive compensation
Flexible work arrangements
Career development opportunities

Fulltime

Vice President, Payments Product Manager

The successful candidate will join the Japan Payments team, focusing on strategi...

Location

Japan , Chiyoda, Tokyo

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Extensive, demonstrable experience in Product Management, including business and strategic leadership experience within the payments landscape, is required
A proven track record as a 'Payments Product Leader' with end-to-end P&L responsibility, market strategy definition, and the ability to influence and drive large-scale initiatives as the owner of their product portfolio is essential
Exceptional leadership and executive communication skills: The ability to inspire, influence, and align diverse senior stakeholders across a complex global organization, as well as external parties including clients, local regulators, the central bank, bankers' associations, and industry peers
A deep and strategic understanding of payment processing, including not just traditional bank transfers but also card and alternative payment method frameworks, messaging standards (e.g., ISO 20022), regulatory frameworks, and data flows, coupled with a forward-looking perspective on emerging payment technologies and market trends
Proven ability to thrive in a fast-paced, high-pressure environment, effectively managing multiple competing priorities simultaneously
Experience in successfully defining, developing, and launching complex, market-leading payment solutions
Mastery in business case development and presenting compelling strategic proposals to senior leadership
Strong analytical and problem-solving abilities, with the ingenuity and creativity to resolve complex, novel, and ambiguous situations
Advanced risk management acumen: A strategic mindset for assessing, documenting, and managing business and regulatory risk within a dynamic product environment
Demonstrated ability to drive cross-functional collaboration, fostering a culture of shared ownership and excellence

Job Responsibility

Define and Execute Vision: Set the strategic vision and long-term roadmap for key payment solutions for your product portfolio, ensuring alignment with global Payments strategy and market opportunities
Drive P&L Ownership: Take full accountability for the P&L growth of your product portfolio, proactively identifying market shifts, understanding complex client needs, and leading the creation and commercialization of winning client solutions from conception to market dominance
Strategic Leadership: Provide decisive leadership in assessing and defining requirements, and overseeing the successful, compliant implementation of critical regulatory mandates and strategic initiatives across payment solutions
Architectural & Experiential Oversight: Develop a deep, strategic understanding of the payments application architecture—not just in its current state, but how it can be evolved to optimally support critical payment flows and deliver a best-in-class end-to-end client experience
Modernization & Innovation Driver: Spearhead modernization initiatives, driving product innovation, end-to-end project execution, and ensuring the successful market adoption of next-generation payment capabilities
Influence & Shape Strategy: Critically contribute to and shape the overarching strategy of Payments in Japan, collaborating with cluster and global teams to continuously enhance our client proposition
Proactive Risk Management: Expertly assess and manage risk with a 'CEO mindset' when making critical business decisions, pre-empting and mitigating potential systemic risks, and escalating, managing, and reporting any issues with the utmost transparency and urgency
Lead AI Integration: Champion and lead high-impact AI-related initiatives within the payments product space, identifying opportunities for competitive advantage and operational efficiency

Fulltime

Select Country

Japan Regulatory Strategy Manager

Amgen

Location:
Japan , Tokyo

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 23, 2026

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