Regulatory Affairs Officer (Mid Level Role)
Lima, Peru
Buenos Aires, Argentina
Bogota, Colombia
Full time
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Job Overview
Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either in‑house 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 (post‑marketing) 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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