Regulatory Affairs Specialist: Submissions & Compliance

IQVIA; Bogotá ciudad; Presencial; COP 26.000.000 - 42.000.000; Jornada completa

Descripción de la vacante

IQVIA in Bogotá seeks a Regulatory Affairs professional to prepare and review regulatory submissions for clinical trials and marketing authorizations. You will support project timelines and collaborate with internal and external clients on regulatory activities.

The role requires a Lifescience degree, 2+ years in regulatory affairs, English fluency, and strong communication skills. Knowledge of US/Canada processes is a plus, with opportunity to grow in a global team.

Formación

• Bachelor’s Degree in Lifescience or related discipline.
• At least 2 years of regulatory affairs (postmarketing) experience.
• 1 year tracking information on regulatory processes.
• Fluent English: Spoken, Read and Written.
• Nice to have worked with USA or Canada.

Responsabilidades

• Prepare and/or review regulatory submissions documents.
• Support regulatory activities and project timelines.
• Participate in project teams and communicate with clients.
• Assist in process improvements and SOP adherence.

Conocimientos

Regulatory knowledge

Project coordination

Communication skills

Microsoft Office

Team collaboration

English fluency

Educación

Bachelor’s Degree in Lifescience

Herramientas

Microsoft Office

Publishing tools

Descripción del empleo

IQVIA in Bogotá seeks a Regulatory Affairs professional to prepare and review regulatory submissions for clinical trials and marketing authorizations. You will support project timelines and collaborate with internal and external clients on regulatory activities.

The role requires a Lifescience degree, 2+ years in regulatory affairs, English fluency, and strong communication skills. Knowledge of US/Canada processes is a plus, with opportunity to grow in a global team.