CrawlJobs Logo

Regulatory Support Excellence – Senior Associate

amgen.com Logo

Amgen

Location Icon

Location:
Japan , Tokyo

Category Icon
Category:
-

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

To support the Regulatory Support Excellence function by ensuring high-quality, consistent, and efficient execution of Japan Regulatory operations, enabling reliable delivery across regulatory activities. The Senior Associate supports the day-to-day execution of regulatory operational processes, documentation, and governance under the direction of the Sr. Manager. This role works in close collaboration with Regulatory Assistants, coordinating and overseeing routine operational activities to ensure tasks are executed accurately, on time, and in alignment with defined processes.

Job Responsibility:

  • Execute standardized regulatory operational processes across submissions, reviews, and post-approval activities
  • Coordinate day-to-day regulatory operational tasks in collaboration with Regulatory Assistants
  • Review outputs prepared by Regulatory Assistants to ensure completeness, accuracy, and adherence to agreed standards
  • Maintain high-quality regulatory documentation and records
  • Support implementation and consistent application of SOPs, operational standards, and RACI
  • Monitor execution against defined processes, identifying gaps or deviations
  • Plan, prioritize, and coordinate operational tasks across Regulatory Assistants
  • Track progress of assigned tasks and proactively address delays, quality issues, or resource constraints
  • Provide clear task-level guidance
  • Support coordination with internal stakeholders
  • Coordinate and support regulatory document formatting activities
  • Review formatted documents for compliance with established templates, formatting rules, and regulatory expectations
  • Operate regulatory systems (e.g., RIM and related tools), ensuring data accuracy and timely updates
  • Support preparation of meeting materials, minutes, and action tracking

Requirements:

  • Bachelor’s degree
  • 3–5 years of experience in regulatory affairs, regulatory operations, or related pharmaceutical functions
  • Solid understanding of regulatory operations and document management
  • Strong attention to detail and execution discipline
  • Ability to manage multiple tasks and timelines concurrently
  • Clear and professional communication skills in Japanese and English
  • Collaborative mindset with a strong sense of accountability

Nice to have:

  • Experience supporting regulatory submissions or regulatory lifecycle management
  • Hands-on experience with regulatory systems (e.g., RIM)

Additional Information:

Job Posted:
February 13, 2026

Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Regulatory Support Excellence – Senior Associate

Cyber Incident Response Senior Associate

A leading global law firm is seeking a skilled associate to join its Cybersecuri...
Location
Location
United Kingdom , Greater London
Salary
Salary:
140000.00 - 170000.00 GBP / Year
https://www.douglas-scott.co.uk Logo
Douglas Scott
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong academic credentials
  • 4–7 PQE in incident response within a national or international law firm
  • Demonstrated ability to manage complex, cross-border cybersecurity incidents
  • Excellent communication and client management skills
Job Responsibility
Job Responsibility
  • Lead and support clients through complex cybersecurity incidents, including data breaches and ransomware attacks
  • Advise on regulatory compliance and risk mitigation strategies
  • Collaborate with multidisciplinary teams to develop and implement incident response plans
  • Contribute to thought leadership and business development initiatives
What we offer
What we offer
  • Collaborative environment
  • Continuous professional development
  • Opportunity to work on high-profile, cross-border incidents
  • Fulltime
Read More
Arrow Right

Housing Solicitor - Senior Associate

An outstanding opportunity has arisen for a Senior Associate to join the thrivin...
Location
Location
United Kingdom , Birmingham
Salary
Salary:
60000.00 - 80000.00 GBP / Year
https://www.douglas-scott.co.uk Logo
Douglas Scott
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Qualified Solicitor, Chartered Legal Executive or Licensed Conveyancer
  • Strong experience with housing associations, especially in the affordable home ownership space
  • Comfortable managing site set-ups and advising developers and investors (desirable but not essential)
  • Passionate about team collaboration, client service, and mentoring junior colleagues
  • Able to work well under pressure, managing a busy caseload and meeting deadlines with a calm, proactive approach
  • Excellent written and verbal communication skills with the ability to build strong client relationships
  • A positive, forward-thinking mindset and a commitment to professional development
Job Responsibility
Job Responsibility
  • Manage a varied caseload of shared ownership, new build, and after-sale transactions, including lease extensions, disposals, RTB/RTA, deeds of variation and more
  • Provide high-quality legal advice to a range of real estate clients, particularly housing associations and developers
  • Contribute to business development initiatives and the continued expansion of the team
  • Ensure compliance with all regulatory and internal policies
  • Actively support junior team members and contribute to their ongoing development
  • Engage with internal training and external networking opportunities
  • Manage billing and work towards income and profitability targets
What we offer
What we offer
  • Flexible working
  • Hybrid options
  • Ongoing technical and career development support
  • Strong culture of mentoring
  • Fulltime
Read More
Arrow Right

Japan Regulatory Strategy Group Senior Manager

The Japan Regulatory Strategy Group Sr Mgr is developing and executing the regul...
Location
Location
Japan , Tokyo
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
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
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
Read More
Arrow Right

Biostatistical Programming Senior Associate

Amgen is expanding its global Statistical Programming capabilities, with Amgen I...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
Job Responsibility
Job Responsibility
  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
What we offer
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
Read More
Arrow Right

Biostatistical Programming Senior Associate

Amgen is expanding its global Statistical Programming capabilities, with Amgen I...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
Job Responsibility
Job Responsibility
  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
What we offer
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
Read More
Arrow Right

Biostatistical Programming Senior Associate

Amgen is expanding its global Statistical Programming capabilities, with Amgen I...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
Job Responsibility
Job Responsibility
  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
What we offer
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
Read More
Arrow Right

Biostatistical Programming Senior Associate

Amgen is expanding its global Statistical Programming capabilities, with Amgen I...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
Job Responsibility
Job Responsibility
  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
What we offer
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
Read More
Arrow Right

Biostatistical Programming Senior Associate

Amgen is expanding its global Statistical Programming capabilities, with Amgen I...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
amgen.com Logo
Amgen
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
Job Responsibility
Job Responsibility
  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP
What we offer
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
Read More
Arrow Right