Japanese Labelling & Artwork Manager
Japanese Labelling & Artwork Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
/Hybrid work model
Please check if the candidate has applied for a job at UCB in the past year.
Please make English and Japanese resume combined in one document to submit
If you have any questions please contact recruiting team
Primary Purpose:
Provides Japanese Labelling & Artwork Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross functional teams.
MAJOR RESPONSIBILITIES
Creation update and maintenance of the Japanese package inserts in line with the CCDS Agency RTQ and most up-to-date labelling requirements and labelling template required in Japan and according to SOPs
If applicable for assigned Early development assets deliver competitive labelling searches and contributes to the TCLP for Japan (collaborating with Global Labeling Lead: GLL)
Key point of contact for the Japanease Package Insert (digital package insert Module 1.8) for internal (GRA strategic Partners in Japan) and external stakeholders (clinical medical legal commercial safety quality and be the Japan labeling representative in team meetings (DTJ Global RST LET Japan Submission Team ). Lead Reviews Round Tables Approvals for the Japan Labeling in the appropriate system and according to SOP
Delivers operational excellence for all labelling activities according to timelines such as appropriate tracking of the Japan labeling in the appropriate system and according to SOP
Linguistic review process for ensure labelling compliance: Lead with local regulatory lead the Linguistic review according to Green book assist with the preparation of the Closing Sequence and ensure communication of HA approved label to internal and external stakeholders according to SOP
Lead the Local Labelling Committee (including but not limited to medical legal commercial safety) for the creation review and approval for the Japan Labeling in the appropriate ECMS and according to SOP. This may also include discussion with relevant cross-functional SMEs and Japanese Health Authorities
Key point of contact for the Japan Artwork for GRA and external stakeholders (medical legal commercial safety quality.
As Japan labelling & artwork expert for assigned Therapeutic Business Unit
the individual will build strong relationships with:
o Japan and Global Regulatory teams
o Local business partners (commercial access medical affairs legal and understand their business needs
o Key partner with SPA for labelling and artwork changes
Monitor changes in Japan labelling and artwork requirements keep the organisation aware of changes in Japanese regulatory requirements.
Education Level : Bachelors Degree
COMPETENCIES
o Build effective partnerships identifies opportunities and takes actions to build effective relationships with internal and external stakeholders gains trust and external networkingInfluencing skills - through well thought through rationale and effective communication skills able to influence key decisions. negotiation and influencing skills to develop regulatory strategies contributing to patient value creation
o Flexibility and adaptability - Decides what to do based on the situation. Changes behaviour or approach to fit the situation or the person. Works effectively in ambiguous situations
o Communication skills knows when and how to communicate using strong interpersonal skills and written communications when appropriate
o Results focused ability to overcome obstacles and achieve key outcomes
o Analytical logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
o Organizational Skills
o Integrity Commitment to integrity and high standards in self and othersRisk management: Anticipates identifies characterizes and escalates risks associated with our products processes and submissions. Identifies and defines research questions and strategy relevant data sources methodologies and systems for benefit safety and Risk Minimization Measures (RMM) effectiveness analysis in a rapidly evolving environment
o Leadership: Lead transversally beyond organizational borders empower hold accountable drive innovation and engage around vision
UCB
UCBUCB8500
UCB
UCBUCBUCB
UCB
UCB
Required Experience:
Manager
Employment Type
Full Time
