Takeda
Pharma
RegulatoryAffairsHeadColombia
“Regulatory Affairs Head Colombia at Takeda. Skills: Regulatory affairs, Product lifecycle management, Submission preparation. Manage investigational applications. Manage market applications”
What You'll Achieve.
Achieve high standards; Deliver results
Industry & Context.
Resolve agency review questions
What They're Looking For.
Must Have
Bachelor's degree, Minimum 7 years experience, Minimum 5 years managing team, Proven experience managing INVIMA, Fluent Spanish, Fluent English
Nice to Have
Chemistry degree preferred, Pharmacy degree preferred, Experience managing consultants, Experience managing authorities Andean Countries
What You'll Do.
Manage investigational applications
Manage market applications
Manage post approval reporting
Manage product lifecycle
Develop submission strategies
Provide regulatory guidance
Assess regulatory impact
Maintain regulatory files archive
Establish regulations library
Provide international regulatory guidance
Assess international regulatory impact
Participate in program teams
Develop relationships with agencies
Develop relationships with consultants
Develop relationships with partners
Develop meeting materials
Chair meetings with agencies
Attend meetings with agencies
Review promotion materials
Review advertising materials
Participate in SG-SST activities
How You'll Work.
Team & Collaboration
Interact with regulatory agencies; Work with management; Work with consultants; Work with partners; Work with program teams; Work with company consultants; Work with company partners
Communication Scope
Verbal communication; Written communication; Internal communication; External communication
Process & Methodology
Project plans, Timelines, Project fees, Project status reports
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