Bristol Myers Squibb
Healthcare
SeniorSpecialist,Labeling&RegulatoryAffairs
“Senior Specialist, Labeling & Regulatory Affairs at Bristol Myers Squibb. Skills: Labeling strategy, Regulatory affairs, Global applications, Marketed products. Provide optimal labeling strategy. Implement optimal labeling strategy”
What You'll Achieve.
Achieve BMSKK business target
Industry & Context.
Problem-solving ability; Analytical thinking
What They're Looking For.
Must Have
Specialized scientific knowledge, Knowledge of R&D process, Latest regulatory knowledge, Experience of regulatory work, Knowledge of local/global org, English communication skills
What You'll Do.
Provide optimal labeling strategy
Implement optimal labeling strategy
Provide labeling strategy support
Implement labeling strategy support
Submit post-marketing applications
Submit labeling updates
Conduct checks on packaging materials
Offer suggestions on information materials
Prepare target labeling draft
Obtain agreement for target labeling
Contribute to optimal labeling strategy
Prepare final labeling draft
Obtain agreement for final draft labeling
Consider regulatory acceptance scenarios
Enhance predictability by providing options
Obtain global agreement on support
Align with regulatory in Japan
Prepare documents for CPP
Carry out procedures with regulatory authorities
Submit query responses
Contribute to labeling revisions
Lead labeling strategy
Conduct checks on packaging materials
Contribute to ensuring compliance
Offer suggestions on information materials
Communicate with regulatory authorities
How You'll Work.
Team & Collaboration
Stakeholder agreement; Global teams; Cross-functional teams; GPS department cooperation
Communication Scope
English communication
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