Regulatory Submissions & Lifecycle Specialist

IQVIA Inc; Puerto Bogotá; On-site; COP 36,000,000 - 60,000,000; Full time

Job summary

IQVIA Inc. is seeking a Regulatory Affairs professional in Colombia to prepare and review regulatory submissions for clinical trials and marketing authorization activities.

You will support small to mid-size projects, coordinate with senior staff, and ensure compliance with applicable laws and guidelines. The role requires 2–3 years of regulatory experience, strong English skills, and the ability to work across development stages from CMC to labeling.

Qualifications

• Bachelor's Degree in Lifescience or related discipline (concluded).
• Master's Degree in Lifescience or related discipline is a plus.
• At least 2 - 3 years relevant experience in Regulatory Affairs in general, Publishing, Word Formatting, Clinical PDF Publishing, Submission Publishing activities.
• Fluent English (writing, speaking, reading).
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
• Good, solid interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable.

Responsibilities

• 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.
• 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.

Skills

Fluent English

Regulatory knowledge

Interpersonal communication

Multi-project handling

Independent thinker

Education

Bachelor's Degree in Life sciences

Master's Degree in Life sciences (plus)

Tools

Microsoft Office

Publishing tools

Job description

IQVIA Inc. is seeking a Regulatory Affairs professional in Colombia to prepare and review regulatory submissions for clinical trials and marketing authorization activities.

You will support small to mid-size projects, coordinate with senior staff, and ensure compliance with applicable laws and guidelines. The role requires 2–3 years of regulatory experience, strong English skills, and the ability to work across development stages from CMC to labeling.