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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a integral CRO can bring? Our team says it’s the best of both worlds….
Empresa confidencial is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.
Empresa confidencial is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
JOB DESCRIPTION
Job Title

REGULATORY AFFAIRS JR ANALYST Consultant

Job Summary

Ensures regulatory data is compliant in all databases. Execute activities such as preparation of labels, update of systems and archives, review regulatory data in internal and external databases. Support submission and approvals of market licenses including changes, renewals and establishment registrations.



Organize and balance a multitude of activities simultaneously.

Scope

Major Roles and Responsibilities

Execute post-approval activities such as review of databases, preparation of communications to stakeholders.
Update systems with regulatory data and documents.
Review labels compliance in internal system.
Execute submission of changes, amendments, rectifications and renewals in timely manner with guidance.
Provide assistance with establishment registration licenses.
Request and follow-up of documentation to prepare registration dossiers.
Supports regional team on product submissions schedules, prioritization, and pipeline management with guidance.
Act as a point of contact for stakeholders to support business plans and regulatory needs.
Support projects as representative of the subject/country.
Organize the archive of the area.
Organize team meetings and elaborate agenda and minutes.
Support compulsory certification activities.

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📌 REGULATORY AFFAIRS JR ANALYST Consultant (Bogotá)
🏢 Importante Empresa Del Sector
📍 Bogotá