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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory Product Submissions and RegistrationJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob Description:
JOB SUMMARY
Under the supervision of their supervisor:
- Develop Japanese package inserts (Japanese PI) based on Japanese target label
- Run Japan Labeling committee process to develop labeling positions for marketed product issues
- Collaborate with Global Labeling and/or CDT on creation/revision of Japanese PI proactively
- Maintain some Japanese PI in post-approval environment and negotiate Japanese labeling of Marketed products with HA
KEY RESPONSIBILITIES
Development J-PI
- Participates in development of labeling negotiation Japanese strategies and development of supporting documentation for Japanese labeling
- Develop Japanese PI from Japanese Target Label
- Update Japanese PI based on updated CCDS and new data
- Interface with tracking function to ensure that changes are being tracked and advise on Japanese label audit
- Run the Japan Labeling Working Group process and participate in these groups
Labeling Committee
- Run Japan Labeling committee process to develop Japanese labeling positions for both development and marketed product issues
- Explain labeling position on proposed labeling at the Japan Labeling Committee
- Prepare final proposed Japanese PI for review by Labeling Working Group and Labeling Committee
Relationship with Global Team
- Serve as a support member of the global Labeling Working Group and provides input on proposed updates to the CCDS/USPI/SmPC
- Receive information on CCDS from Global Labeling and disseminate it to relevant people in JANSSEN JAPAN
- Communicate with Global Labeling and/or CDT on creation/revision of Japanese PI
- Share information with Global Labeling on US/EU/Japan labeling and act as a window to it
- Provide support in preparing responses to Call for Information in preparation of PSURs regarding Japanese input (Approval information: Indication, Dosage and Administration etc).
Post approval maintenance
- Maintain Japanese PI in post-approval environment
- Revise Japanese PI and provide input on implementation timelines as necessary
- Provide labeling support necessary to defend the company labeling position in Japan when issues arise
- Team with Japanese Labeling Therapeutic area representatives and collaborate with partners including Health Authorities, Manufacturing, Regulatory Operations, and Regulatory Affairs etc in Japan.
Interactions with HA
- Negotiate Japanese labeling of post-approval products with HA (ensure alignment with global strategy) as appropriate
- Review Japanese PI in preparation for meeting with Health Authorities
Print Labeling and others
- Execute the technical aspects of labeling process (e.g., partner with Japan Submission Operations to prepare labeling submissions, and with Graphic Services to develop artwork for implementation in packaging and website display)
- Prepare Japan unique explanatory documents called "Kaisetsusho" which explains rationale for "Precautions for Use" included in new drugs' J-PI.
- Ensure effective quality control of labels
REQUIREMENTS
Experience/Knowledge
- A minimum of 3 years of pharmaceutical industry experience (clinical development, safety, regulatory affaris) and/or experience associated with product labeling/labeling regulations is required.
Skills/Capabilities
- Good verbal and written communication skills in Japanese/ English is required. TOEIC score: over 700
Qualification/Certificate
- A minimum of Bachelor degree in a scientific discipline, especially pharmaceutical science, is preferred.
•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, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented-
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