Head of clinical ra Job at Randstad (苏州市)

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

Amgen is a global leader in biotechnology with a history of more than four decad...

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
Advanced degree preferred
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

Job Responsibility

Developing and executing the regulatory strategies and plans
Providing strategic regulatory expertise for drug development
Interfacing with regulatory authorities
Aligning with key cross-functional partners
Integrating into Amgen's commercialization process
Continuously improving business processes
Developing and implementing the Japan regulatory strategy, aligned with global regulatory strategy
Providing guidance on local mechanisms to accelerate/optimize product development and regulatory approvals
Proactively influencing developing the global regulatory strategy so that Japan developments are aligned
Consistently looking for opportunities to accelerate the developments/approval and/or increase the value of the program

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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

New

Purchasing Specialist

We are looking for a Purchasing Specialist to support the material planning func...

Location

United States , St Paul

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Bachelor's degree in business or a related field
0-2 years of experience in procurement, purchasing, planning, or a comparable supply chain role
Strong Microsoft Excel skills with the ability to work confidently in spreadsheets and analyze data sets
Clear verbal and written communication skills with strong attention to detail
Ability to interpret supply plans, identify gaps, and explain findings to internal stakeholders
Proficiency with Microsoft Office applications

Job Responsibility

Build and update supplier forecast reports by combining information from procurement systems and Excel-based tracking tools
Review planning and purchasing data to uncover shortages, timing issues, and other risks that could disrupt supply availability
Track outstanding purchase orders and follow up with vendors to secure confirmations, revisions, and updated delivery information
Work with planners, procurement partners, and suppliers to address material constraints and keep orders aligned with business needs
Prepare targeted analyses and reporting that help the team make informed purchasing and planning decisions
Organize and validate data from multiple sources to improve forecast accuracy and support daily operational priorities

What we offer

Medical, vision, dental, and life and disability insurance
Company 401(k) plan

New

Bank Care Assistant

About Us... Advinia has been providing high quality, person-centred care, specia...

Location

United Kingdom , Bloxwich

Salary:

13.45 GBP / Hour

Advinia Healthcare

Expiration Date

June 24, 2026

Requirements

Fantastic people skills
Supportive and great at communicating
Able to build strong relationships and empathise
Caring by nature
Enthusiastic person-centred approach with a genuine passion for making people's lives brighter each day
Great team player
Adaptable
No experience required

Job Responsibility

Respecting the Residents’ dignity and privacy
Providing the highest standard of person-centred support to the Residents’ to be as independent as possible and encouraging them to do as much for themselves as they can
Working with Residents’ and families to deliver person centered care
Supporting with all aspects of personal care
feeding, toileting, bathing
Maintaining thorough and up to date records on each Residents’

What we offer

Free DBS/PVG check
Competitive pay rates
Flexible pay
Paid Family Leave
5.6 weeks annual leave per annum (pro rata per hours worked)
A fantastic working environment
Free uniform
Professional training and ongoing career progression

Parttime

New

Senior Care Assistant

Our talented Senior Care Assistants lead our Care Teams to provide the highest s...

Location

United Kingdom , Dumfries

Salary:

15.50 GBP / Hour

Advinia Healthcare

Expiration Date

June 18, 2026

Requirements

NVQ Level 3 Health and Social Care or equivalent
experience within a similar role
leader
fantastic people skills
caring by nature
great team player
adaptable

Job Responsibility

Administering medication
Providing hands on, high quality Resident Care
Team supervisions
Developing, implementing and updating care plans
Adhering to CQC guidelines
Coaching and mentoring your team whilst identifying training needs

What we offer

Free DBS/PVG check
Professional training and ongoing career progression
Flexible pay
A fantastic working environment
Free uniform
Ongoing training and career progression opportunities

Fulltime

New

Payroll Administrator

This is an exceptional opportunity to join one of the UK’s fastest growing contr...

Location

United Kingdom , Ringwood

Salary:

Not provided

Knights Brown

Expiration Date

Until further notice

Requirements

Experience in a similar role is preferable

Job Responsibility

Support the Lead Payroll Administrator across all areas of payroll processing and preparation
Accurately process monthly and bi-weekly payroll inputs within required deadlines
Calculate, process, and monitor all elements of pay, including overtime, bonuses, allowances, and deductions
Liaise with HR, employees and line managers to resolve payroll-related queries in a timely manner
Process statutory and voluntary deductions, including court orders and CSA payments, ensuring accurate monthly remittance to the relevant authorities
Prepare and submit pension data via the auto-enrolment portal, ensuring correct calculation and application of pension deductions
Submit finalised payroll data to the Lead Payroll Administrator and Finance Manager for approval and payment
File all necessary payment submissions on-line information with HMRC
Coordinate auto-enrolment communications by providing relevant correspondence to HR for distribution to employees
Support payroll-related projects and carry out additional ad hoc tasks as required

Fulltime

New

Host

As a Host in our Leeds venue, you will play a vital role in ensuring our guests ...

Location

United Kingdom , Leeds

Salary:

10.85 - 12.71 GBP / Hour

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Previous experience in a Host or front-of-house role within Catering & Hospitality is desirable
Excellent communication and interpersonal skills with a friendly, approachable manner
Strong organisational skills and the ability to multitask in a busy environment
Ability to remain calm under pressure and deliver exceptional customer service
Basic IT skills for managing bookings and seating plans
Flexibility to work evenings, weekends, and bank holidays as required
A genuine passion for hospitality and creating a welcoming atmosphere for guests

Job Responsibility

Warmly greeting guests upon arrival and managing waiting lists efficiently
Coordinating bookings and seating arrangements to optimise the dining experience
Providing accurate information about menus, specials, and promotions
Handling guest enquiries and resolving any issues promptly and professionally
Maintaining a clean and organised reception and waiting area
Collaborating closely with front-of-house and kitchen teams to ensure smooth service flow
Supporting health and safety and hygiene standards in line with company policies

What we offer

Competitive hourly pay between £10.85 and £12.71, reflecting your skills and experience
Part-time, permanent role providing stability and a great work-life balance
Training and development opportunities to support your career growth in hospitality
A friendly and inclusive team environment where your contributions are valued
Employee discounts and special offers across East Coast Concepts venues
Supportive management committed to your success and wellbeing

Parttime

Select Country

Head of clinical ra

Job Description

Requirements

Looking for more opportunities?