Regulatory Affairs Junior Associate (Colombia)

Contract: 12 months

Location: Colombia, Bogota (hybrid)

We are seeking a detail-oriented Regulatory Affairs Associate to ensure the integrity and compliance of regulatory data across databases. This role involves preparing product labels, maintaining and updating regulatory systems and archives, reviewing internal and external databases, and supporting the submission and approval process for market licenses, changes, renewals, and establishment registrations. The ability to organize and manage multiple activities simultaneously is essential.

Key Responsibilities:

• Execute post-approval activities such as database reviews and stakeholder communications

• Update regulatory systems and maintain records/documentation

• Review and ensure label compliance in internal systems

• Support timely submissions for changes, amendments, and renewals, with guidance

• Assist with establishment registration licenses

• Prepare registration dossiers by requesting and following up on documentation

• Support regional product submissions, schedules, prioritization, and pipeline management

• Serve as a point of contact for stakeholders to support regulatory needs

• Represent the subject/country in relevant projects

• Organize team archives, meetings, agendas, and minutes

• Support certification activities as needed

Competencies:

• Strong planning and organizing skills

• Analytical and investigative abilities

• Ability to manage deadlines and prioritize workload

• Adherence to compliance

• Competence in data management, especially with Excel

Qualifications:

• Experience in regulatory affairs or submission preparation for Colombian Health Authorities is desirable

• Previous experience in healthcare companies preferred

• Bachelor’s degree in Engineering, Pharmacy, or Life Sciences; relevant experience or training may be considered

• Intermediate English writing and reading skills

• Fluent in Portuguese