Global Regulatory Submissions Specialist

IQVIA; Manila; Hybrid; PHP 500,000 - 700,000; Full time

Job summary

IQVIA is seeking a Regulatory Publishing Specialist to support peer publishers and eCTD leads in preparing study reports, submissions, and related documents for internal or external clients. You will perform quality control reviews, collect appendices, and assist with document publishing.

Responsibilities include preparing and reviewing regulatory submission documents (NDAs, INDs, 510(k)s, annual reports, PSRs, variations, renewals).

Qualifications

• Bachelor’s degree in a life science-related discipline; 3–7 years industry experience preferred.
• Basic knowledge of regulatory requirements (GCP, ICH) and SOPs, or willingness to learn.
• Strong communication skills (verbal, written, aural).
• Strong organizational and time management skills.
• Proficient in Microsoft Office and web-based applications.
• Attentive to detail and accuracy; able to maintain quality standards.
• Ability to follow instructions, work independently and use initiative.
• Proven ability to multi-task and manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills; self-motivated and flexible.

Responsibilities

• Prepare and/or review regulatory submission documents to support clinical and marketing authorization activities.
• Create, assemble and publish major and routine global submissions (NDAs, INDs, 510(k)s, Annual Reports, PSRs, Supplements, Variations, Renewals).
• Support regulatory affairs in coordination, preparation, and submission of submissions.
• Handle pre-publishing (bookmarks/hyperlinks), compilation, post-publishing validation, and lifecycle management submissions.
• Track project timelines, coordinate with senior staff, and manage day-to-day workload.
• Perform QC to ensure integrity and quality of each published unit.
• Plan, prepare, track, and archive regulatory documents in paper and electronic formats.
• Maintain FDA/Regulatory correspondence and ensure timely filing in document management systems.
• Collaborate with clinical, nonclinical, CMC, regulatory to ensure compliance with style guides.
• Participate in project teams and communicate confidently; stay updated on regulations governing controlled documents.

Skills

Communication

Organization

Time management

Attention to detail

Independent work

Learning mindset

Multi-tasking

Self-motivation

Education

Bachelor's degree in life sciences

Tools

MS Office

Adobe Acrobat

Electronic Document Management Systems

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

IQVIA is seeking a Regulatory Publishing Specialist to support peer publishers and eCTD leads in preparing study reports, submissions, and related documents for internal or external clients. You will perform quality control reviews, collect appendices, and assist with document publishing.

Responsibilities include preparing and reviewing regulatory submission documents (NDAs, INDs, 510(k)s, annual reports, PSRs, variations, renewals).