10 nov
|
Nautas
|
Quilmes
Bogota, ColombiaMexico City, MexicoBuenos Aires, ArgentinaFull timeR
Job Overview
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients.
Provides regulatory support for assigned projects.
Essential Functions
Acts as a Regulatory Team Member on small, straightforward regulatory projects and/or gets involved in a small single service project, under the guidance of senior staff.
Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable.
Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
Understands the Scope of Work, deliverables for any given project.
May prepare slides and background material for small, straightforward business development meetings under senior guidance and presents in client meetings by phone or in person.
May prepare and deliver trainings, as appropriate.
Performs other tasks or assignments, as delegated by Regulatory management.
Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.
Qualifications
Bachelor's Degree in Lif
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