Reg Affairs Specialist

IQVIA Inc; Ciudad de México; Sur place; MXN 391 000 - 781 000; Plein temps

Résumé du poste

IQVIA is seeking a Regulatory Affairs professional to prepare and/or review regulatory submission documents supporting clinical trials and marketing authorization activities. Under supervision, you will provide regulatory support for assigned projects and collaborate with internal and external customers.

You will participate in small projects as a regulatory team member, track timelines, and help with publishing activities, file management, and training as needed.

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 R&D process, laws and guidelines, as appropriate.
• Good interpersonal communication and organizational 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 SOPs and contribute to process improvements.
• Ability to make decisions on discrete tasks under supervision.
• Requires advanced knowledge within a discipline.
• Ability to suggest enhancements in systems and processes.

Responsabilités

• Prepare and/or review regulatory submissions documents.
• Provide regulatory support for assigned projects.
• Act as Regulatory Team Member on small projects under guidance.
• Identify project needs, track timelines, and manage workload.
• Prepare slides and background material for small business development meetings.
• May prepare and deliver trainings.
• Support management with system/process improvements.
• Handle updates in systems to resolve problems.

Connaissances

Regulatory knowledge

English fluency

Project coordination

Interpersonal communication

Organizational skills

Formation

Bachelor's degree in Life sciences

Master's degree in Life sciences (a plus)

Outils

Microsoft Office

Publishing tools

Word formatting

Clinical PDF Publishing

Submission Publishing

Description du poste

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.