Regulatory Affairs Specialist

About the role

IQVIA is looking for a Regulatory Affairs Specialist in Bogota. Working under general supervision, you will prepare and/or review regulatory submission documents supporting clinical trial and marketing authorization activities for internal and/or external clients, and provide regulatory support for assigned projects.

Key responsibilities

• Act as a regulatory team member on small, straightforward projects or single-service projects under the guidance of senior staff.
• Identify project needs, track timelines, implement client requests and manage day-to-day workload with senior staff.
• Prepare and/or review regulatory documentation in your area of expertise.
• Participate in project teams with internal and external customers and communicate confidently.
• Understand the scope of work and deliverables of each project.
• May prepare slides and background material for business development meetings and present in client meetings by phone or in person.
• May prepare and deliver training sessions.
• Perform other tasks delegated by regulatory management and make minor changes to systems and processes to solve problems.

Required profile

• Bachelor's degree in Life Sciences or a related discipline; a Master's degree is a plus.
• At least 2-3 years of relevant experience in Regulatory Affairs, including publishing, word formatting, clinical PDF publishing and submission publishing.
• Fluent English (writing, speaking, reading).
• Good understanding of the R&D process (CMC, preclinical and clinical), and of the relevant laws and guidelines.
• Strong oral and written communication, organization and interpersonal skills.
• Ability to work on several projects under the direction of senior staff and to follow standard operating procedures.
• Applicable certifications and licenses as required by local regulatory bodies.

Required skills

• Microsoft Office and publishing applications and tools.
• Regulatory knowledge in areas such as CMC, lifecycle maintenance, marketing authorization transfers, labeling and publishing.