Global Program Regulatory Manager Japan

Job Description Summary

-Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment.

 

Job Description

Major accountabilities:

• Achieve the best product registration with commercially attractive labelling in accordance with registration plan -Maintain and secure product license in terms of CMC/CDS/safety update according to local regulations/law/guidelines, company strategy and global compliance -Ensure compliance with NP4, KRPIA code of conduct, relevant regulations and laws for related CPO activities (DRAGON update, RMP, packing materials, promotional materials/activities, PMS/drug safety reporting etc.) -Foster and maintain good relations with internal and external stakeholders -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Project & stakeholder feedback -Product license update in terms of CMC in agreed timeline -Adherence to Novartis policy and guidelines

Minimum Requirements:
Work Experience:

• Functional Breadth.
• Cross Cultural Experience.
• Operations Management and Execution.
• Project Management.

Skills:

• Analytical Skill.
• Clinical Trials.
• Collaboration.
• Detail Oriented.
• Lifesciences.
• Project Planning.
• Regulatory Compliance.

Languages :

• English.

 

Skills Desired

Analytical Skill, Clinical Trials, Communication, Detail-Oriented, Life Science, Project Planning, Regulatory Compliance