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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:
JOBSUMMARY:
- 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
KEYRESPONSIBILITIES:
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
- ThoroughknowledgeofGQP-relatedactivities aswellas1+years working experienceoftherelevantactivitiesoranequivalent 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
