Global Regulatory Submissions Specialist

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

Job summary

IQVIA Inc. seeks a Regulatory Submissions Specialist to prepare and review regulatory documents for clinical trials and marketing approvals. You will publish and validate major and routine submissions and support cross-functional teams across regulatory affairs.

Responsibilities include coordinating submissions, maintaining electronic document management, and ensuring adherence to regulatory guidelines. Strong communication, organization, and life-sciences training are essential.

Qualifications

• Bachelor’s degree in life science-related discipline; 3–7 years in regulatory/publishing.
• Knowledge of GCP/ICH guidelines and SOPs is preferred.
• Strong communication, organization, and attention to detail.

Responsibilities

• Prepare/review regulatory submissions documents for clinical trials and marketing authorization.
• Create, assemble, and publish major and routine submissions (NDAs, INDs, 510(k)s, annual reports, etc.).
• Support regulatory affairs in coordination, preparation, and submission of submissions.
• Pre-publish (bookmarks/links), compile, post-publish, and validate submissions.
• Maintain documents and FDA/EU/ICh correspondence and ensure compliance.

Skills

Regulatory knowledge

Documentation coordination

Attention to detail

Communication skills

Education

Bachelor's degree in life sciences

Tools

MS Office

Adobe Acrobat

EDMS

Job description

IQVIA Inc. seeks a Regulatory Submissions Specialist to prepare and review regulatory documents for clinical trials and marketing approvals. You will publish and validate major and routine submissions and support cross-functional teams across regulatory affairs.

Responsibilities include coordinating submissions, maintaining electronic document management, and ensuring adherence to regulatory guidelines. Strong communication, organization, and life-sciences training are essential.