Japan Regulatory Strategy Group Senior Manager Job at Amgen (Tokyo)

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

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

Senior Manager, Corporate Finance

Location

United States , Columbus

Salary:

185460.00 - 190000.00 USD / Year

Aflac

Expiration Date

Until further notice

Requirements

Must have a Bachelor’s degree in Finance, Accounting, Economics, or a related quantitative field plus at least 10 years of progressive experience in corporate finance positions
Must have at least 5 years of experience in a supervisory/managerial capacity in corporate finance space performing the following duties: Overseeing the collection of capital policy and funding information to support global treasury teams in aligning with strategic objectives
Sharing insights on financial markets and regulatory trends, focusing on U.S. and Japan financial environments
Managing team members in effectively utilizing financial and operational information
Liaising with cash operations and corporate finance teams as part of ongoing business activities
Providing leadership and guidance in developing capital strategies tailored to unique organizational needs
Exploring and evaluating cash management systems in collaboration with global treasury counterparts
Developing funding and liquidity risk management strategies from a global perspective
Leading cross-functional teams to achieve project goals across multiple initiatives, including system conversions, capital efficiency improvements, and inaugural bond issuances
Coordinating with internal and external stakeholders such as executive leadership, regulatory agencies, legal counsel, and auditors to ensure alignment and compliance

Job Responsibility

Contribute to and develop global capital markets strategy for Aflac related to accessing global debt capital markets and managing foreign exchange risk, including planning and execution
Identify opportunities and strategies relative to Aflac's FX risk profile, mainly Japanese Yen denominated, to mitigate risk and lower costs
Oversee and perform sensitivity FX and interest rate analysis on status quo and pro-forma derivative portfolios
Assist in negotiating ISDA/CSA documents with counter parties including Japanese financial institutions
Assist in debt raising and credit facility analysis and execution, including terms, due diligence, internal communication, and related activities
Develop and leverage internal partnerships with FP&A, Tax, Legal, Financial Reporting, Accounting Policy, Investor and Rating Agency Relations, etc. and external partnerships with counsel, banks, accounting firms, and networks to maximize the achievement of team and corporate goals
Lead corporate finance modeling, liquidity, and capital structure optimization analysis and clearly communicate analysis and recommendations to senior management
Support strategic analysis, financial modeling, reporting on derivative activity, reporting on capital markets activity, and approval requests for capital markets activity for Aflac's leadership team, both on a recurring and ad hoc basis
Perform other duties as required

Fulltime

Japan Clinical Leader

Responsible for clinical development of the assigned project in Japan under the ...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Scientific background in education
>3 years or more experience in clinical development
Experience in clinical development
Thorough understanding of the processes associated with clinical and regulatory submissions
Skill to design and execute development strategies (e.g. advanced medical and pharmaceutical knowledge, skill to design development strategies, knowledge on clinical study operations including guidelines and SOPs, skill to think logically, innovatively, and flexibly, writing skills)
Leadership skills
Team building skills, networking skills
Negotiation skills, consensus building skills
Problem solving skills
Project management skills

Job Responsibility

Evaluate candidates for development in the assigned TA/DA from scientific and technical aspects and formulate an effective development plan for Japan with the JDL and the global team
Contribute to establishing the global development plan by discussing points to consider in developing the product (including biomarkers and diagnostics) and obtaining approval in Japan (e.g. medical practice, communication with the government) with the global team and considering strategies towards early launch
Establish good working relationships with internal and external stakeholders [e.g. key opinion leaders (KOL), academic society, patient group] to enhance the possibility of expedited development and early approval with the JDL and senior JCL
Lead Japan Development Team (JDT) and clinical studies of assigned project to success in cooperation with JDT and global team members
Communicate closely with the GCL and Clinicians in Worldwide Research and Development (WRD) and respective Business Units (BU) and build and execute an effective development strategy
Prepare high quality documents (e.g.study outline, briefing document, CTD, query response, publications) and review them
When a Clinical Scientist (CS) is assigned to the project, review the documents prepared by the CS (e.g. full protocol, informed consent document, investigator's brochure)
when a CS is not assigned, the JCL is responsible to prepare and review these documents
Contribute to the preparation of the risk management plan for J-NDA submission and other documents required after approval
Review clinical data and protocol deviations and determine necessary actions for clinical studies in which he/she is the Clinical Lead

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

Fulltime

Senior Manager Validation

Reporting to the Associate Director of Validation, the Senior Manager of Validat...

Location

Ireland , Dun Laoghaire

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Typically 8+ years of experience in management position
Typically 4+ years' experience supervising validation / technical staff
Graduate degree in Science (Microbiology, Cell Biology, Biochemistry an advantage) or Engineering
Significant experience working in a GMP environment within the pharmaceutical/biotechnology industry in the areas of process, plant, equipment, cleaning, analytical methods and computer systems validation
Detailed knowledge of the regulatory requirements across a range of geographies but particularly the US, EU, Canada, Australia and Japan
Substantial experience within the biotechnology sector, with prior experience in the areas of sterile liquid filling, packaging and labelling an advantage

Job Responsibility

Lead in the development of Validation’s vision, mission, strategies, goals and objectives
Maintain, implement and continuously develop a Validation strategy
Responsible for providing Validation expertise in area of equipment sterility, aseptic processing simulation (or media fill) and temperature mapping
Manage the qualification/validation of production equipment, utilities and systems directly associated with sterility of equipment and processes
Provide support for Tech Transfers (NPIs and LCMs) and regulatory submissions
Oversee the preparation, execution, documentation and reporting of validation studies
Responsible for the development, revision, review, and approval of Standard Operating Procedures
Strong people and project management skills with proven ability to define and execute the validation elements of a projects from design to routine facility operation
Capable of creating a team environment among existing site groups and creating a unified culture within the validation organization
Assure the appropriate level of training is undertaken for all levels of the validation organization

Fulltime

New

Support Worker (SEN)

Level Up Your Career: Make a Real Impact as an SEN TA. Looking for a role that a...

Location

United Kingdom , Cranleigh

Salary:

90.00 - 95.00 GBP / Day

Randstad

Expiration Date

June 18, 2026

Requirements

experience working with young people with SEN
must have a car and license
full Enhanced DBS check upon onboarding

Job Responsibility

support students 1-on-1, helping them navigate their day and unlock their potential
work with teachers to make lessons vibe with how different students learn
be a consistent, positive face for students who need someone in their corner
gain hands-on experience in the SEN sector

What we offer

PAYE
referral bonus
training and education
safeguarding & prevent training

Fulltime

New

1:1 Teaching Assistant

This role is to start ASAP or September so if this sounds like the job for you, ...

Location

United Kingdom , Cranleigh

Salary:

20566.00 - 24501.00 GBP / Year

Randstad

Expiration Date

June 11, 2026

Requirements

Teaching Assistant Qualification (desirable but not essential)
Relevant teaching Assistant and SEN experience (Must be able to provide references)
Eligibility to work in the UK

Job Responsibility

Supporting a SEN learner on a 1:1 basis
Supporting a primary aged learners with a severe and complex needs
Working with the teacher to support the learning objectives

What we offer

Local free parking available
Ready supply of tea, cakes and biscuits in the modern and spacious staff room
Discounted childcare available
On-site training
Bright and spacious classrooms with top of the range resources and technology
Supportive Senior leadership

Fulltime

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Japan Regulatory Strategy Group Senior Manager

Job Description

Job Responsibility

Requirements

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