Regulatory Submissions Specialist (Life Sciences)

IQVIA Inc; Ciudad de México; Presencial; MXN 391.000 - 781.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

English fluency

Project coordination

Interpersonal communication

Organizational skills

Educación

Bachelor's degree in Life sciences

Master's degree in Life sciences (a plus)

Herramientas

Microsoft Office

Publishing tools

Word formatting

Clinical PDF Publishing

Submission Publishing

Descripción del empleo

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.