Chiyoda Johnson & Johnson Innovative Medicine
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.

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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
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