Manager, Japan Regulatory Affairs Strategy Job at Randstad (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

Corporate Affairs Senior Manager

We are seeking a dynamic and experienced Senior Manager of Corporate Affairs to ...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree and 6 years of Communications and/or Advocacy experience
Bachelor’s degree and 4 years of Communications and/or Advocacy experience
Fluent in Japanese and English
Proven experience in corporate communications, public affairs, or public relations or an adjacent field, within healthcare, pharmaceuticals, or biotechnology
Strong ability to understand business priorities and contribute to effective, strategic communication plans
Skilled at translating complex topics into creative yet compliant storytelling that aligns with commercial and corporate goals
Demonstrated success working in a multinational, matrixed organization, leading through influence and aligning diverse stakeholders
Proven ability to work cross-culturally across JAPAC and global teams
Understanding and appreciation of Japanese culture, landscape, and stakeholder expectations and communication approaches
Strong interpersonal skills and ability to work collaboratively across teams

Job Responsibility

Develop and deliver impactful product communications for launches of new medicines and expanded indications
Execute integrated communications strategies across media, emerging media, social and digital media to support corporate priorities, therapeutic areas, and key brand milestones and opportunities
Contribute to strengthening Amgen K.K.’s reputation through clear and authentic storytelling that resonates with key audiences across Japan
Develop and lead an advocacy engagement strategy that fosters trusted relationships with patient advocacy groups, to amplify the patient voice and support improved access to care
Drive disease and patient education communications in partnership with the Brand team including Marketing, Medical, and Value and Access functions
Collaborate with cross-functional partners, including Commercial, Government Affairs, Medical, Legal, Regulatory, to deliver communication activities that highlight Amgen’s commitment to innovation and contribution to Japanese society
Support internal communication efforts to help foster a connected, energized employee culture
Leverage generative AI and analytics tools to elevate quality, speed, and personalization of communications, improve working efficiency, and unlock actionable insights that inform strategies and optimizations
Coordinate best practices and learnings with colleagues in the JAPAC region and the Global Corporate Affairs team
Oversee vendors, when appropriate, ensuring high-quality execution, compliance, and budget discipline

Director, Regulatory Affairs - In-Vitro Diagnostics (IVD)

Amgen is seeking a Director of Regulatory Affairs to work in their Thousand Oaks...

Location

United States , Thousand Oaks

Salary:

210840.00 - 251128.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of directly related experience
Master’s degree and 7 years of directly related experience
Bachelor’s degree and 9 years of directly related experience
Substantial experience leading CMC/Device Regulatory Affairs strategy and execution for products in differing stages of the product lifecycle
Experience of leading and/or participating in meetings with regulators in major markets (US, EU, Japan and China)
Knowledge of global CMC/Device regulations and understanding of evolving challenges and health authority expectations
Track record as a strong coach and mentor

Job Responsibility

Manage and mentor the IVD regulatory affairs team, fostering talent retention and promoting a culture of inclusion, diversity, and collaboration
Oversee resource allocation and operational strategies to effectively support the complex development pipelines
Develop regulatory positions, best practices, and SOPs to ensure efficient support for submissions and approvals
Lead cross-functional and global teams on regulatory issues, ensuring seamless communication and collaboration across all stakeholders
Lead the team to navigate IVD/CDx regulatory pathways, including the drug/diagnostics co-development process, clinical performance studies, analytical validations, and post-market compliance
Direct the team to develop and execute regulatory planning and submissions (e.g., PMA, 510(k), IDE) to achieve approvals across multiple regions, including the US, EU, Japan, and China
Collaborate with diagnostic partners on co-development programs, ensuring alignment and compliance
Utilize regulatory tools, such as databases and frameworks, for efficient content planning and reporting
Ensure the team’s adherence to regulations, guidance and international standards, including ISO 13485, ISO 14971, and CLSI guidelines
Design and implement global regulatory strategies that align with business goals and product development timelines

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

Fulltime

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

Personnel performing work affecting product quality shall be competent based on appropriate education, training, skills and experience.
B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry.
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques.
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures.
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices to ensure the manufacturing and distribution of products comply with applicable regulatory requirements.
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers.
Establish and administer the supplier audit program for quality/regulatory compliance.
Maintain the Approved Supplier List (ASL).
Support the Global Supplier Review Board, including providing metrics for supplier assessments.
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits.
Provide guidance as needed for corrective action required because of assessment findings.
Execute supplier audits in accordance with approved schedules.
Support documentation of supplier changes through the supplier notification, change management, QNC, or CAPA processes.

What we offer

comprehensive and competitive range of benefits
Total Rewards package
pay
health care benefits
retirement plans
work/life benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria

Lung cancer MAS team lead

Acts as a line manager leading a team of MAS. Shapes the local strategy and ensu...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Minimum requirement: 4-year university undergraduate degree AND master’s degree in life science, or Pharmacists >4-year university graduates with pharmacist license and master’s degree or equivalent life science research experience, or >6–year university graduates with pharmacist license, or Nurses with a master’s degree, or Veterinarians, or Dentists, or MDs
Preferred: MD (clinical experience, board certification preferred), or PhD in Life Science
Experience in the pharmaceutical industry, preferably as a Medical/Scientific Advisor, MSL, team lead, and/or clinical experience with direct patient care and/or professional experience in the pharmaceutical industry in relevant areas
MA/DJ experience and / or research experience preferred
Scientific publication
Strategic Thinking: Ability to consider the direction of Medical from a mid-to-long-term perspective and formulate strategies as a manager at Pfizer
Communication Skills: Ability to conduct clear and efficient communication, including with other departments, and convey information accurately and logically
Decision-Making Ability: Ability and responsibility to make quick and effective decisions even in situations where there is no clear answer
Leadership: Ability to influence teams and departments and drive them towards achieving organizational goals
Financial Skills: Ability to manage budgets and execute actions reliably and on schedule

Job Responsibility

Acts as a line manager leading a team of MAS
Shapes the local strategy and ensures the delivery of scientific-medical expertise and exchange with KOLs in the assigned therapeutic area
Lead the Pfizer Japan medical scientific point of contact for HCPs, medical societies, regulators, academia and other external stakeholders
Play a central role as a scientific and medical leader who can identify unmet medical needs(UMRs), drive the building and executing medical plans and oversee establishment of clinical evidence
Demonstrate medical and scientific leadership and expertise
Ensure and oversee the highest scientific standards during in / external activities to provide deep medical and scientific expertise
Lead development of local medical plan aligned with global medical plan to address local UMRs and fill data gaps, and manage implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines
Direct and supervise providing and exchanging medical/scientific information for/from medical facilities in the assigned area and external stakeholders and make strategic decisions on medical strategies for assigned products
Drive and monitor heightened understanding of the burden of disease in the assigned therapeutic area and medical attributes of our products to enhance the safe and efficacious use
Lead achievement of department/team goals, and/or manage cross-organizational projects, providing guidance and accountability for results

Fulltime

Amyloidosis, Medical Affairs Scientist

The MAS role family comprises a variety of medical scientific specialties, such ...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Minimum requirement: 4 year university undergraduate degree AND master’s degree in life science, or Pharmacists 4-year university graduates with pharmacist license and master’s degree or above or equivalent life science research experience, or 6–year university graduates with pharmacist license, or Nurses with master’s degree or above, or Veterinarians, or Dentists, or MDs
Preferred: In addition to those who meet the minimum requirements above, the qualifications below are preferred MD (clinical experience, board certification preferred), or PhD in Life Science
Technical Skills: Medical/ pharmaceutical expert knowledge of therapeutic disease area/ products
Ability to communicate appropriately and build good relationship with internal/external stakeholders
Work effectively with teams and across functions by demonstrate Pfizer’s Values & Behaviors and the agility to learn from others
Capable of medical discussion with relevant departments and external HCPs.
A person who understands compliance and relevant laws/regulations in the pharmaceutical industry and advocates the appropriate use of the products.
Can demonstrate appropriate knowledge and understanding of internal organization structure, key stakeholders and strategies
A person who is able to quickly acquire necessary medical/ scientific knowledge and skills though self-learning
Experience: Work experience at functions of: Medical Affairs

Job Responsibility

Demonstrate medical and scientific leadership and expertise
Provide and exchange medical/ scientific information for/from medical institutions (and other related sources) in the assigned area and from stakeholders.
Drive for heightened understanding of the clinical and medical attributes of our products in order to enhance the safe and efficacious use.
Maintain the highest scientific standards during in/ external activities to provide deep medical and scientific expertise.
Contribute to the implementation of local medical strategies and life cycle clinical plans for inline and pipeline medicines / vaccines to address unmet medical needs and fill data gaps.
Make important contributions to decisions of medical strategies for assigned products, in order to ensure safe, proper, and effective use of assigned products.
Contribute to achieving the department/team goals, and/or participate in cross-organizational projects as a core member and provide guidance to deliver the results.
Play an active role in supporting members in the team/organization with the line manager to move towards its goals
Develop and execute the medical plan aligned with the medical strategy to meet unmet medical needs in the assigned product(s) and therapeutic area(s) in collaboration with office medical
Identify unmet medical needs and healthcare disparities in the assigned asset(s) and therapeutic area(s) through medical activities such as advisory board meetings and scientific exchanges with HCPs and other relevant individuals and organizations.

Fulltime

Principal Supplier Quality Engineer

This position provides technical leadership for Supplier Quality Management proc...

Location

United States , Alpharetta

Salary:

Not provided

Avanos

Expiration Date

Until further notice

Requirements

B.S. in Engineering, Science, Business, or another relevant field
Minimum of 10 years of collective experience in a Research, Manufacturing, Quality and/or Regulatory Affairs function within a medical device, pharmaceutical, biologic, or other highly regulated industry
Supplier Quality Engineering experience in the Medical Device industry
Strong understanding of Risk Management principles and techniques
Knowledge of Statistical Techniques
Experience in root cause analysis and failure investigation tools
Working knowledge of the MDSAP Single Audit program including the regulations for US, Japan, Canada, Australia, and Brazil
Working knowledge of the key medical device compliance related standards such as ISO 13485, ISO 14971, ISO 19011, ISO 10993, etc.
Certification as CQA, CBA, MDA, or ISO 13485 Lead Auditor
Strong project management skills

Job Responsibility

Ensure conformance to industry practices, domestic and international regulatory requirements and established company procedures
Provide technical leadership for Supplier Quality Management processes and activities
Implement, coordinate, support, and monitor activities related to the Global Supplier Quality Management (SQM) activities across Avanos
Train R&D, Technical Quality, Operations, and other functions on the established processes
Provide global technical leadership in the development and implementation of quality and regulatory compliance strategies and best practices
Lead cross-functional collaboration with Procurement, R&D/Operations, Technical Quality, and Logistics teams to address quality issues at contract manufacturers and suppliers
Establish and administer the supplier audit program for quality/regulatory compliance
Maintain the Approved Supplier List (ASL)
Support the Global Supplier Review Board, including providing metrics for supplier assessments
Actively engage with suppliers in the event of a supplier issue requiring corrective action or upcoming external audits

What we offer

comprehensive and competitive range of benefits
Total Rewards package
health care benefits
retirement plans
work/life benefits
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
uncapped sales commissions

Fulltime

Senior Director, Vaccines Medical Affairs Lead

Provide scientific leadership for the vaccine business in Japan. Develop and exe...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD)
10+ years of Medical Affairs experience in vaccines/infectious diseases, including 7+ years of people leadership
Proven track record in national-level strategy development and execution for new product launches/indication expansions
Experience in scientific dialogue with PMDA, MHLW, municipalities, and academic societies (presentations, chairing, committee participation)
Practical understanding of Pharmaceutical Affairs Law, GCP, GPSP, GVP, Clinical Research Law, Personal Information Protection Law, JPMA Code
Deep expertise in vaccine-related Medical Affairs
Leadership: Inspire, develop, and lead teams in dynamic environments with scientific excellence
Communication and relationship-building skills across internal and external stakeholders
Compliance: Promote appropriate use through understanding of industry regulations
Learning agility: Ability to quickly self-learn necessary medical/scientific knowledge

Job Responsibility

Develop annual Medical Affairs Plans (MAPs) aligned with Japan’s infectious disease epidemiology, NIP (National Immunization Program), local implementation, and decision-making processes
Lead launch preparation and execution for new products, indications, and technologies
Identify unmet medical needs and healthcare disparities via advisory boards
create and drive action plans to address data gaps
Lead unbiased scientific communication, HCP education seminars, data generation initiatives, and development of scientific materials
Contribute to lifecycle planning for both inline and pipeline vaccines
Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science
Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation
Oversee publication and conference presentation plans
Support investigator-initiated studies and medical grants per internal policy

Fulltime

Manager, Japan Regulatory Affairs Strategy

Randstad

Location:
Japan , Tokyo

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 19, 2026

Expiration:
July 29, 2026

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