Regulatory Affairs Officer (Mid Level Role)
Lima, Peru
Buenos Aires, Argentina
Bogota, Colombia
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 Lifescience or related discipline.
- 2-3 years of regulatory affairs (postmarketing) experience: maintenance records, new records, regulatory activities.
- 1 year tracking information on regulatory processes.
- Fluent English: Spoken, Read and Written.
- It's a plus to have worked with other countries:

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