Bogota, Colombia
Mexico City, Mexico
Buenos Aires, Argentina
Full time
R

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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