Submit your CV Looking to hire
en
en

Jobs

Let our industry specialists listen to your aspirations and present your story to the organisations in Japan that fit you the best as we collaborate to write the next chapter of your successful career.

See all jobs
Accounting & finance Explore your full potential with roles where you're more than just a number. Automotive Take your pick from the latest roles across the automotive industry in Japan. Banking & financial services Let us help match you with roles at the most coveted organisations. Chemical Explore new opportunities in the chemical industry. Digital Level up your career by working in a cutting edge digital role. Energy & infrastructure Let us help match you with roles at the most coveted firms. Healthcare, medical & pharmaceutical Explore a new chapter in the healthcare, medical and pharmaceutical sectors. Human resources Secure a role where you’re empowered to help people be the best they can be. Industrial & electrical Build a career within an organisation of the forefront of national progress. Legal, compliance & risk Take your pick from Japan's most prestigious in-house and legal firm roles. M&A advisory & consulting Connect with employers where your expertise in advisory and consulting is seen and valued. Marketing Play an instrumental part in the story of leading brands and employers. Retail Discover a new chapter in the world of retail as we help you find the ideal sales professional role that suits your unique talents and ambitions. Sales Not all sales professionals and roles are the same, let us help you find the right one for you. Secretarial & business support Connect with employers where your administration skills are seen and valued. Supply chain & procurement Making things better, smoother, faster. That's were you come in to make a difference. Tax & assurance Connect with employers where your tax & assurance expertise is seen and valued. Technology & transformation Level up your career by working on cutting edge projects and technology in Japan.
Submit your CV Looking to hire

Candidates

Together, we’ll map out career-defining, life-changing pathways to achieve your career ambitions. Browse our range of services, advice, and resources.

Learn more
Career advice Insights to help you progress your professional story. Submit your CV Let us help you write the next chapter in your career. Tell us you story today. International career management Your career has no borders. Learn how you can take your talents to the world. Refer your friend Refer a friend and get rewarded. Salary calculator Benchmark your salary and explore the hiring trends in your industry. Our expertise Need advice or more information about a specific industry or role? No worries. Our specialist teams at Robert Walters Japan have you covered. Find jobs Our industry specialists will listen to your aspirations and share your story with the most prestigious organisations in Japan. Together, let’s write the next chapter of your career.
Career Advice Top Talent Trends In Recruitment 2024
Career Advice How to succeed in a new senior leadership role
Career Advice Guide for moving to Japan: Helpful tips for new movers
Submit your CV Looking to hire

Services

Japan's leading employers trust us to deliver fast, efficient hiring solutions that are tailored to their exact requirements. Browse our range of bespoke services and resources

Read more
Submit your CV Looking to hire

Insights

Whether you’re seeking to hire talent or seeking a new career move for yourself, we have the latest facts, trends and inspiration you need.

See all resources
E-guides and whitepapers Get access to the latest expert research, reports and insights. Podcasts Access our Powering Potential podcast series to hear from business leaders and recruitment experts. Career advice Guiding you on your career journey. Hiring advice Resources and advice to get the best out of your workforce. Webinars Watch industry workforce leaders exchange ideas and reveal new trends. Salary survey Get the most comprehensive overview of salaries and hiring trends in your industry from the Robert Walters Salary Survey.
Hiring Advice Unlocking the power of middle managers
Hiring Advice Maximise the middle
Hiring Advice Japan's Talent Crisis
Submit your CV Looking to hire

About Robert Walters Japan

For us, recruitment is more than just a job. We understand that behind every opportunity is the chance to make a difference to people’s lives

Learn more
Our story Learn more about our history and who we are. Investors Access the latest investor news from Robert Walters. Partnerships Partnerships with purpose. Learn more about the people and organisations we partner with. Equity, diversity & inclusion It starts from within. Learn how our workplace promotes inclusion, diversity and respect for all. Our client and candidate stories Read more about how we champoin the stories of our candidates, clients. ESG and corporate responsibility Learn more about our ESG commitments and how we are helping people and planet. FAQs Check out frequently asked questions regarding your account.

Work for us

Our people are the difference. Hear stories from our people to learn more about a career at Robert Walters Japan.

Learn more
Submit your CV Looking to hire

Contact Us

Truly global and proudly local. Speak to us today on your recruitment needs.

Get in touch

Offices

Submit your CV Looking to hire
Jobs

Let our industry specialists listen to your aspirations and present your story to the organisations in Japan that fit you the best as we collaborate to write the next chapter of your successful career.

See all jobs
Candidates

Together, we’ll map out career-defining, life-changing pathways to achieve your career ambitions. Browse our range of services, advice, and resources.

Learn more
Career Advice Top Talent Trends In Recruitment 2024
Career Advice How to succeed in a new senior leadership role
Career Advice Guide for moving to Japan: Helpful tips for new movers
Services

Japan's leading employers trust us to deliver fast, efficient hiring solutions that are tailored to their exact requirements. Browse our range of bespoke services and resources

Read more
Insights

Whether you’re seeking to hire talent or seeking a new career move for yourself, we have the latest facts, trends and inspiration you need.

See all resources
Hiring Advice Unlocking the power of middle managers
Hiring Advice Maximise the middle
Hiring Advice Japan's Talent Crisis
About Robert Walters Japan

For us, recruitment is more than just a job. We understand that behind every opportunity is the chance to make a difference to people’s lives

Learn more

Work for us

Our people are the difference. Hear stories from our people to learn more about a career at Robert Walters Japan.

Learn more
Contact Us

Truly global and proudly local. Speak to us today on your recruitment needs.

Get in touch
Submit your CV Looking to hire

薬事スペシャリスト/ Regulatory Affairs Specialist

Save job

An international regulatory solutions firm is searching for a Medicinal Products – Regulatory Affairs Specialist. The selected candidate will be responsible for processing applications for CPP, GMP, and ML requests to PMDA.

Responsibilities:

  • Coordinate with assigned stakeholders and CMO sites for timely obtaining of the GMP certificate
  • Process the application of the GMP request to PMDA and the GMP compliance inspection application
  • Coordinate with assigned stakeholders and CMO sites for timely obtaining of the ML certificate
  • Process the application of a manufacturing license request to PMDA
  • Receive request orders
  • Receive the certificate from CMO sites or PMDA and then send it to the requester
  • Prepare a dashboard for periodic communication indicating key performance

Requirements:

  • Experience in handling Japan's PMDA HA submissions and applications for COPP, GMP, and ML
  • Good understanding of statutory documents
  • Strong written and verbal communication skills

About the Company:

Based overseas, this international company offers end-to-end regulatory and technology services that benefit life science firms.

Keywords:

RA, 規制, 法令, ライフサイエンス, 外資系

2097900/001

About the job

Contract Type: TEMPORARY

Specialism: Healthcare

Focus: Regulatory Affairs

Industry: Medical and Nursing

Salary: Negotiable based on experience

Workplace Type: On-site

Experience Level: Associate

Location: Tokyo

Job Reference: 2097900/001

Date posted: 09 September 2024

Consultant: Akito Shimizu

Phone number: +81 3 4570 1750

akito.shimizu@robertwalters.co.jp

Akito Shimizu

Save job

Share

Similar jobs

  • ライフサイエンススペシャリスト/ Life Sciences Specialist
    Salary: ¥8,000,000 - ¥20,000,000 per annum
    Location: Tokyo
    Date posted: 01 October 2024
    A global management consulting firm is looking for a Life Sciences Specialist. The selected candidate will address client challenges while receiving comprehensive training in strategic business consulting.
    Read more
  • MSLマネージャー/ MSL Manager
    Salary: ¥13,000,000 - ¥18,000,000 per annum
    Location: Tokyo
    Date posted: 21 September 2024
    An international pharmaceutical company is looking for an MSL Manager. The selected candidate will lead, guide, and support a team of MSLs to align with company objectives.
    Read more
  • メディカルアドバイザー/ Medical Advisor
    Salary: ¥13,000,000 - ¥18,000,000 per annum
    Location: Tokyo
    Date posted: 15 September 2024
    An international pharmaceutical company is searching for a Medical Advisor. The selected applicant will be in charge of supporting the Medical Lead in the development and implementation of the medical plan.
    Read more
  • 薬事シニアマネージャー/ Regulatory Affairs Senior Manager
    Salary: ¥8,000,000 - ¥18,000,000 per annum
    Location: Tokyo
    Date posted: 29 August 2024
    A pioneering pharmaceutical company is looking for a Regulatory Affairs Senior Manager. The selected candidate will work with global teams to define regulatory strategies and manage the submission of regulatory documents.
    Read more
  • Head of Marketing
    Salary: ¥12,000,000 - ¥17,000,000 per annum
    Location: Tokyo
    Date posted: 20 August 2024
    A renowned pharmaceutical company is seeking a Head of Marketing. The selected candidate will develop and execute strategic marketing plans, lead the marketing team, and ensure business objectives are met.
    Read more
  • 臨床開発医師// Clinical Research Physician
    Salary: ¥15,000,000 - ¥20,000,000 per annum
    Location: Tokyo
    Date posted: 08 August 2024
    外資系老舗製薬会社にて臨床開発医師の募集がございます。中枢神経疾患領域の医学専門家として新薬の開発早期から薬剤ライフサイクルすべての時期において活動をリードしていただきます。在宅勤務制度が導入されています
    Read more
View more jobs

I'm Robert Walters Are you?

Come join our global team of creative thinkers, problem solvers and game changers. We offer accelerated career progression, a dynamic culture and expert training.

Work for us