Global Regulatory Submissions Specialist

IQVIA Inc; Makati; On-site; PHP 446,000 - 781,000; Full time

Job summary

IQVIA Inc is seeking a Regulatory Operations professional to support regulatory submissions and document publishing. You will prepare, review, and assemble submissions for global trials, ensuring compliance with regulatory standards.

Responsibilities include coordinating with cross-functional teams, maintaining document control, and delivering accurate publications in line with client requirements. A degree in life sciences and knowledge of FDA/ICH guidelines are preferred.

Qualifications

• Bachelor’s degree in life science; preferred understanding of Regulatory Affairs.
• Experience with regulatory submissions processes and documentation control.
• Strong written and verbal communication skills.
• Excellent organizational and time‑management abilities.
• Proficiency with MS Office and electronic document management systems.
• Knowledge of GXP, FDA/ICH guidelines is advantageous.

Responsibilities

• Under supervision, prepare and review regulatory submission documents for internal or external clients.
• Create, assemble, and publish global paper and electronic submissions (NDAs, INDs, 510(k)s, etc.).
• Support Regulatory Affairs in coordinating and submitting documents.
• Pre-publish, validate, and post-publish regulatory submissions.
• Track timelines, manage workload, and coordinate with senior staff.

Skills

Regulatory submissions

Quality control

Document publishing

Project coordination

Communication skills

Education

Bachelor’s degree in life sciences

Tools

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

IQVIA Inc is seeking a Regulatory Operations professional to support regulatory submissions and document publishing. You will prepare, review, and assemble submissions for global trials, ensuring compliance with regulatory standards.

Responsibilities include coordinating with cross-functional teams, maintaining document control, and delivering accurate publications in line with client requirements. A degree in life sciences and knowledge of FDA/ICH guidelines are preferred.