Regulatory Submissions & Publishing Specialist

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

Job summary

IQVIA in Manila seeks a Regulatory Submissions Specialist to support the preparation, review, and publishing of study reports and regulatory submissions for internal and external clients. You will coordinate documents, perform QC, and ensure compliance with FDA, EMEA, and ICH guidelines.

The role requires a life sciences degree and 3–7 years of experience, with strong communication and organizational skills. This position offers professional growth and exposure to global regulatory activities.

Qualifications

• Bachelor’s degree in a life science-related discipline with 3–7 years in regulatory publishing.
• Knowledge of GCP/ICH guidelines and SOPs is desirable.
• Strong written and verbal communication; detail-oriented.

Responsibilities

• Prepare and review regulatory submission documents to support clinical trials and marketing activities.
• Create, assemble, and publish global paper and electronic submissions (NDAs, INDs, 510(k)s, reports).
• Support coordination and submission of regulatory documents with cross-functional teams.
• Pre-publish (bookmarks, hyperlinks), compile, post-publish, and validate submissions.
• Maintain FDA correspondence and document management in electronic systems.
• Collaborate with authors to ensure compliance with style guides and templates.
• Assist in training and share knowledge with team; manage workload and timelines.
• Resolve day-to-day inquiries from team members; self-starter with time management.

Skills

Regulatory knowledge

Regulatory publishing

Attention to detail

Time management

Communication skills

Independent worker

Education

Bachelor’s degree in life sciences or related

Tools

MS Office

Adobe Acrobat

EDMS

Veeva Vault

RIM Smart

eCTDXpress

Extedo

Lorenz

Insight

Job description

IQVIA in Manila seeks a Regulatory Submissions Specialist to support the preparation, review, and publishing of study reports and regulatory submissions for internal and external clients. You will coordinate documents, perform QC, and ensure compliance with FDA, EMEA, and ICH guidelines.

The role requires a life sciences degree and 3–7 years of experience, with strong communication and organizational skills. This position offers professional growth and exposure to global regulatory activities.