Chiyoda myGwork - LGBTQ+ Business Community

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.

Please do not contact the recruiter directly.

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional


All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description


JOB SUMMARY:
Management of licenses for Marketing Authorization Holder (MAH)
Management of Foreign Manufacturer Accreditation (FMA)
Management of periodic Good Manufacturing Practice (GMP) inspection
Supports all regulatory activities associated with the registration and maintenance of approved drug products

Key Responsibilities

Manufacturing Authorization Holder (MAH)

Manage and maintain the Open Approval system lists for marketed products.
Conducts procedures for new registration/renewal/change of MAH.

Foreign Manufacturer Accreditation (FMA)

Manage and maintain the lists of FMA.
Conduct procedures for new registration/renewal/change of FMA.
Conduct an annual survey to confirm changes.

Periodic GMP inspection

Manage the schedule of periodic GMP inspection.
Prepare the material of periodic GMP inspection with the Commercial Quality (CQ) members and handle inquiries from PMDA.

Regulatory Support for marketed products

Handle life cycle management on approved matters and Post Marketing Commitment (PMC).
Provide the appropriate advice regarding the regulatory activities
Communicate with Health Authority for the resolution of a regulatory issue

Others

Verification of labels on packages:
Confirm that labels on packages are designed in accordance with regulations.

Verification of materials:
Confirm that materials are created in accordance with regulations and promotion codes.

Handle requests for information disclosure:
Confirm that appropriate descriptions are masked and contact with regulators.
Support JCoT activities for post-marketing regulatory activities as a JCoT member

Requirements

Experience/Knowledge


Thorough knowledge of GQP-related activities as well as 1+ years working experience of the relevant activities or an equivalent carrier.

Skills/Capabilities

Solid communication and computer skills are required.
Must be proficient at speaking and writing both Japanese and English, with good written and oral communication skills.

TOEIC score:
over 700

〈 For Internal Applicants 〉

Based on your experience and interview evaluation, the position title and level may vary.
If you are Japan employee, please read "Internal Application Guideline" in Ask GS.

Especially if you are less than 18 months in your current role, you are required to obtain application approval from your current manager as well as your respective BUHR.

If you are Japan's employee, you are not able to apply for multiple positions at once.

For Employee Referral Program (ERP), please read and understand the details of the "Internal Referral Overview" on the Ask GS and you have made a compliant referral.

Required Skills


Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
Show more Show less

  • Chiyoda Johnson & Johnson Innovative Medicine ¥4,500,000 - ¥6,500,000 per year

    Management of licenses for Marketing Authorization Holder (MAH), Management of Foreign Manufacturer Accreditation (FMA), Management of periodic Good Manufacturing Practice (GMP) inspection, Supports all regulatory activities associated with the registration and maintenance of app ...


  • Chiyoda myGwork - LGBTQ+ Business Community ¥3,000,000 - ¥5,000,000 per year

    This job is with Johnson & Johnson.We believe health is everything. · , Management of licenses for Marketing Authorization Holder (MAH) · Management of Foreign Manufacturer Accreditation (FMA) · Supports all regulatory activities associated with the registration and maintenance o ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time¥60,000 - ¥120,000 per year

    Management of licenses for Marketing Authorization Holder (MAH), management of Foreign Manufacturer Accreditation (FMA), management of periodic Good Manufacturing Practice (GMP) inspection, and support of all regulatory activities associated with the registration and maintenance ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥1,200,000 - ¥2,500,000 per year

    The R&D Specialist/Manager is responsible for leading Japanese regulatory strategy and target labeling in J-CDT, sharing information with the Global Regulatory Team (GRT), and participating in GRT meetings to provide Japanese input. ...


  • Chiyoda myGwork - LGBTQ+ Business Community ¥1,300,000 - ¥1,800,000 per year

    This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT) · Princ ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time$120,000 - $180,000 per year

    Lead Japanese regulatory strategy and target labeling in J-CDT, and share the information to the Global Regulatory Team (GRT). Prepare Common Technical Document (CTD) for Japan. Provide input on study design, conduct, and need for any additional studies for Japan. · ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥2,000,000 - ¥2,800,000 per year

    The Manager/Specialist of Medical Affairs will conduct medical affairs activities for Janssen Hematology brands primarily focused on proper usage and value maximization. · Develop overall strategy for Hematology portfolio to address medical and scientific issues. · Collaborate wi ...


  • Chiyoda MSD Full time

    +Lead strategic planning and tactical execution for Oncology brands in respective therapeutic areas+Engage with external stakeholders such as Scientific leaders and medical communities+Develop materials and tools used for effective promotion across Omni channel approaches.+Ensure ...


  • Chiyoda MSD Full time$80,000 - $120,000 per year

    The Marketing Specialist will lead the strategic planning and tactical execution for Oncology brands in respective therapeutic areas. · Engage with external stakeholders · Build internal and external stakeholder support · ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time$120,000 - $140,000 per year

    The Manager/Specialist of Medical Affairs, Hematology will be responsible for conducting Medical Affairs (MA) activities for the Janssen Hematology brands primarily focused on proper usage and value maximization. · The Manager/Specialist will be an expert in medical strategy deve ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time¥4,500,000 - ¥6,500,000 per year

    Senior Finance Analyst, reporting directly to Japan R&D Finance Controller (Manager). This position requires a self-motivated individual who can demonstrate strong operational and strategic financial leadership capabilities while engaging in Pharma R&D business processes. · Provi ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥2,000,000 - ¥2,300,000 per year

    This position entails ensuring Innovative Medicine Japan's business practices align with internal rules, · and act as HCC contact for business. · Serving as primary point of contact · for compliance-related matters · ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time¥600,000 - ¥1,200,000 per year

    +Job summary · This position entails ensuring Innovative Medicine Japan's business practices align with internal and external rules.+Possessing a high level of integrity with good ethical values at the core. · Possessing strong communication, organizational and analytical skills. ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥1,200,000 - ¥2,200,000 per year

    This position is open to candidates with either an MD or non-MD background. We are seeking a Clinical Lead/Clinical Development – TA Oncology to provide clinical leadership in JP project team to evaluate JP clinical inputs/recommendation to global clinical development strategy. · ...


  • 東京都 千代田区, Johnson & Johnson ¥2,000,000 - ¥2,800,000 per year

    This position entails ensuring Innovative Medicine Japan's business practices and activities in particular its will support business from the perspective of value transfer based on internal and external rules. · Working closely with team members to ensure interactions are planned ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time¥5,000,000 - ¥10,000,000 per year

    The Japan Clinical Leader (JCL) is responsible for the development and execution of the clinical development strategy for the target indication in the assigned compound, aiming to obtain regulatory approval in Japan. · Develop clinical development strategy for the target indicati ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥5,000,000 - ¥10,000,000 per year

    A Senior, Local Trial Manager is a mid-level trial management role with typically at least 2 years of clinical trial management or 3-5 years for clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation a ...


  • Chiyoda Johnson & Johnson Innovative Medicine Full time¥8,000,000 - ¥15,000,000 per year

    Lead, Local Trial Manager is a senior trial management role with at least 4 years of clinical trial management experience or more than 6 years of clinical monitoring experience. This role is responsible for local management of a clinical trial (or Medical Affairs data generation ...


  • Chiyoda Wells Fargo ¥900,000 - ¥1,200,000 per year

    The Compliance Specialist will sit within the APAC Country Compliance team under Legal Entity Compliance and play a key role in supporting the Japan Chief Compliance Officer with local activities and wider Compliance Programme elements, as required. · Support the Japan Chief Comp ...


  • Chiyoda Johnson & Johnson Innovative Medicine ¥10,000,000 - ¥20,000,000 per year

    Johnson & Johnson Innovative Medicine is recruiting for a Medical Director Clinical Science Oncology. The successful candidate will oversee and ensure the flawless execution of assigned clinical studies in Japan, and contribute to the global clinical development strategy via prov ...

  • Product Manager

    1週間前


    Tokyo MGI ¥2,000,000 - ¥2,800,000 per year

    About MGI: MGI is one of the subsidiaries of BGI Group, which is committed to building core tools and technology to lead life science through intelligent innovation. With a focus on R&D, production, and sales of DNA sequencing instruments, reagents, and related products... · ...