Regulatory Submissions & Publishing Specialist

IQVIA Inc; Pasig; On-site; PHP 600,000 - 1,200,000; Full time

Job summary

IQVIA Inc is seeking a Regulatory Submissions Specialist to prepare and review documents for clinical trial and marketing authorization activities. You will publish major and routine submissions and provide regulatory support across projects.

The role requires collaboration with clinical, regulatory, and publishing teams, strong attention to detail, and proficiency with electronic publishing tools. This position is based in Metro Manila, Pasig, Philippines, with on-site requirements.

Qualifications

• Bachelor’s degree in a life sciences field; understanding of Regulatory Affairs preferred.
• Knowledge of GCP/ICH guidelines and SOPs or willingness to learn.
• Strong communication skills (verbal, written, aural).
• Organizational and time management skills; detail-oriented.

Responsibilities

• Prepare and/or review regulatory submissions documents for clinical trial and marketing authorization activities.
• Provide regulatory support for assigned projects.
• Create, assemble, and publish global paper and electronic submissions (NDAs, INDs, 510(k)s, annual reports, PSRs, variations, renewals).
• Coordinate and submit documents in collaboration with regulatory affairs personnel.
• Pre-publish, compile, post-publish, and validate regulatory submissions; manage lifecycle submissions.

Skills

Regulatory knowledge

Communication

Time management

Attention to detail

Independent work

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

IQVIA Inc is seeking a Regulatory Submissions Specialist to prepare and review documents for clinical trial and marketing authorization activities. You will publish major and routine submissions and provide regulatory support across projects.

The role requires collaboration with clinical, regulatory, and publishing teams, strong attention to detail, and proficiency with electronic publishing tools. This position is based in Metro Manila, Pasig, Philippines, with on-site requirements.