Remote Regulatory Affairs Consultant - Client-Facing (Contract)

ClinChoice; Colombia; Presencial; COP 30.000.000 - 60.000.000; Jornada completa

Descripción de la vacante

ClinChoice is seeking a Regulatory Affairs Associate Consultant for a 12-month contract to support international regulatory submissions and client-facing activities. This role requires strong regulatory expertise, leadership, and the ability to work independently in a global CRO environment.

The position emphasizes high-quality deliverables, accountability, and collaboration across cross-functional teams in a dynamic client-focused setting.

Formación

• 3+ years regulatory experience.
• Demonstrated ability to support international product approval.
• Ability to work in a demanding environment with strong focus on quality and timelines.
• Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.

Responsabilidades

• Accountable for aligned markets regulatory in-scope ancillaries and samples.
• Understand aligned markets regulatory ancillary requirements.
• Manage aligned markets ancillary and samples requests to meet timelines for regulatory submissions.
• Work in a matrix environment with effective communication across multiple functions.
• Escalate to Client and Contractor contacts when timelines may not be reached.
• Maintain Clients systems and processes to reflect requests in real time.

Conocimientos

Regulatory experience

International product approvals

Leadership and teamwork

Advanced Microsoft Office

Strong communicator

Decisive and accountable

Learning quickly and applying new regs

Educación

Bachelor’s degree

Herramientas

Microsoft Office Suite

Descripción del empleo

ClinChoice is seeking a Regulatory Affairs Associate Consultant for a 12-month contract to support international regulatory submissions and client-facing activities. This role requires strong regulatory expertise, leadership, and the ability to work independently in a global CRO environment.

The position emphasizes high-quality deliverables, accountability, and collaboration across cross-functional teams in a dynamic client-focused setting.