Regulatory Submissions & Publishing Specialist

IQVIA; Taguig; On-site; PHP 600,000 - 900,000; Full time

Job summary

IQVIA is seeking a Regulatory Submissions Specialist to support preparation and review of study reports, submissions, and related documents for internal and external clients. You will publish, QC, and archive regulatory materials across global programs using electronic publishing tools.

Key duties include coordinating with clinical, CMC, and regulatory teams; ensuring compliance with guidelines; and managing timelines to deliver accurate submissions in a fast-paced environment.

Qualifications

• Bachelor's degree in a life science-related discipline; familiarity with regulatory affairs and publishing is preferred.
• Strong communication, organization and time management abilities.
• Proficient in MS Office; detail-oriented with high accuracy.
• Able to work independently and collaboratively in teams; willingness to learn.

Responsibilities

• Prepare or review regulatory submission documents for clinical trial and marketing activities.
• Create, assemble, and publish global submissions (NDAs, INDs, 510(k)s, annual reports, variations).
• Support regulatory affairs coordination and document management throughout submissions.
• Pre-publish, compile, post-publish, and validate regulatory submissions; lifecycle management.
• Track timelines, manage day-to-day workload, and liaise with regulatory sources to ensure compliance.
• Perform QC to ensure integrity and quality of published units.
• Maintain regulatory and FDA correspondence in electronic document management systems.

Skills

Communication

Organization

Time management

MS Office

Attention to detail

Initiative

Education

Bachelor's degree in life science

Tools

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

IQVIA is seeking a Regulatory Submissions Specialist to support preparation and review of study reports, submissions, and related documents for internal and external clients. You will publish, QC, and archive regulatory materials across global programs using electronic publishing tools.

Key duties include coordinating with clinical, CMC, and regulatory teams; ensuring compliance with guidelines; and managing timelines to deliver accurate submissions in a fast-paced environment.