# Regulatory Affairs Specialist

**Company**: IQVIA
**Location**: Bogota
**Experience**: mid
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bogota-Colombia/Reg-Affairs-Specialist_R1578582?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_036f7bc6-c24

## Description

We are seeking a Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will provide regulatory support for assigned projects, prepare and review regulatory submissions documents to support clinical trial and marketing authorization activities for internal and external clients.

**Essential Functions**

- Act as a Regulatory Team Member on small, straightforward regulatory projects and get involved in small single-service projects under senior staff guidance.

- Identify project needs, track project timelines, implement client requests, and manage day-to-day workload in collaboration with senior staff.

- Utilize regulatory knowledge in Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Publishing as applicable.

- Prepare and review regulatory documentation in areas of expertise.

- Participate in project teams with internal and external customers independently and communicate confidently in straightforward matters.

- Understand the Scope of Work and deliverables for given projects.

- Prepare slides and background material for small business development meetings under senior guidance and present in client meetings by phone or in person.

- Prepare and deliver trainings as needed.

- Perform other tasks or assignments delegated by Regulatory management.

- Make minor changes in systems and processes to solve problems.

**Qualifications**

- Bachelor's Degree in Life Sciences or related discipline.

- Master's Degree in Life Sciences or related discipline is a plus.

- At least 2-3 years of relevant experience in Regulatory Affairs, Publishing, Word Formatting, Clinical PDF Publishing, and Submission Publishing activities.

- Fluent English (writing, speaking, reading).

- Good understanding of the Research and Development process, laws, and related guidelines.

- Solid interpersonal communication 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.

- Demonstrates self-motivation and enthusiasm.

- Ability to work on several projects with direction from senior staff.

- Ability to follow standard operating procedures consistently and provide independent thought to assist in process improvements.

- Ability to make decisions on discrete tasks under senior supervision.

## Skills

### Required
- Regulatory Affairs
- Life Sciences
- Microsoft Office
- English

### Nice to have
- Master's Degree in Life Sciences
- Publishing applications and tools

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Source: [Apply at iqvia.wd1.myworkdayjobs.com](https://iqvia.wd1.myworkdayjobs.com/en-US/IQVIA/job/Bogota-Colombia/Reg-Affairs-Specialist_R1578582?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)