Reg Affairs Specialist

MSC Quintiles Mexico S. de R.L. de C.V.; Bogotá; On-site; COP 90,000,000 - 130,000,000; Full time

Job summary

IQVIA is seeking a Regulatory Affairs professional to support clinical trial filings and marketing submissions. You will contribute to project teams and prepare documentation under supervision, communicating clearly with clients and colleagues.

Responsibilities include tracking timelines, delivering presentations, and assisting with trainings. A Lifescience degree and 2–3 years of regulatory experience are preferred, with strong English skills.

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, Publishing and Submission activities.
• Fluent English (writing, speaking, reading).
• Solid understanding of R&D processes (Chemistry, Manufacturing & Controls).
• Strong communication and organization skills.
• Ability to work with clients and coworkers effectively.
• Proficient with Microsoft Office and publishing tools; shows initiative.
• Self-motivated and enthusiastic; able to handle multiple projects.
• Ability to follow SOPs and contribute to process improvements.
• Decision-making on discrete tasks under supervision.
• Advanced knowledge within a discipline based on experience/education.
• Implements enhancements in systems/processes to boost effectiveness.
• Problems faced are generally not highly complex.
• Applicable certifications/licenses as required by regulations.

Responsibilities

• Acts as Regulatory Team Member on small projects under guidance.
• Identifies needs, tracks timelines, and manages workload with seniors.
• Prepares and reviews regulatory documentation in area of expertise.
• Participates in project teams with internal/external clients.
• Prepares slides/backgrounds for small business meetings and presents when needed.
• May deliver trainings as appropriate.
• Performs other tasks delegated by Regulatory management.
• Makes minor system/process changes to resolve common problems.

Skills

Fluent English

Interpersonal communication

Project coordination

Independent thinking

Education

Bachelor's Degree in Lifescience or related discipline

Master's Degree in Lifescience or related discipline

Tools

Microsoft Office

Publishing tools

Clinical PDF Publishing

Job description

Job Overview

Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.

Essential Functions

• 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.
• Experienced in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable.
• 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.
• May prepare and deliver trainings, as appropriate.
• Performs other tasks or assignments, as delegated by Regulatory management.
• Responsible for making minor changes in systems and processes to solve problems where problems faced are not typically difficult or complex.

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.
• Demonstrates self-motivation and enthusiasm.
• Ability to work on several projects, with direction from senior staff as appropriate.
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements.
• Ability to make decisions on discrete tasks under senior supervision.
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
• Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Problems faced are general and may require understanding of broader set of issues, but typically are not complex.
• Applicable certifications and licenses as required by country, state, and/or other regulatory bodies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.