Global Regulatory Submissions Specialist

IQVIA Inc; Taguig; On-site; PHP 480,000 - 700,000; Full time

Job summary

IQVIA Inc is seeking a Regulatory Operations professional to support preparation, review, and publishing of regulatory submissions and study documents for internal and external clients in the Philippines.

You will coordinate with clinical, regulatory, and publishing teams, ensure compliance with GCP/ICH guidelines, and manage electronic documents using Veeva Vault and related tools.

This is a full-time position in Pasig City.

Qualifications

• Bachelor’s degree in a life science-related discipline, preferred understanding of Regulatory Affairs in general, Publishing with 3 to 7 years of industry experience.
• Basic knowledge of clinical research regulatory requirements, i.e. GCP and ICH guidelines, SOPs or willingness to gain.
• Strong communication skills (verbal, written and aural).
• Strong organizational skills and time management skills.
• Proficient in Microsoft Office and web-based applications.
• Attentiveness to detail and accuracy; ability to maintain quality standards.
• Ability to follow instructions/guidelines, utilize initiative and work independently.
• Proven ability to multi-task, manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills.
• Self-motivated and flexible.

Responsibilities

• Prepare and/or review regulatory submissions documents to support clinical trial/marketing activities.
• Create, assemble, and publish global submissions (NDAs, INDs, 510(k)s, Annual Reports, PSRs, Variations, Renewals).
• Coordinate with Regulatory Affairs for submissions.
• Pre-publishing, compilation, post-publishing, and validation of submissions.
• Identify project needs, track timelines, and manage day-to-day workload with senior staff.
• Perform QC to ensure integrity of each published unit.
• Maintain regulatory submissions in paper and electronic formats.
• Liaise with cross-functional areas to ensure compliance with style guides.
• Participate in project teams and communicate confidently.
• Maintain up-to-date knowledge of FDA, EMEA, ICH regulations.
• Represent Regulatory Ops on projects when needed.
• Track deliverables with authoring community.

Skills

Communication skills

Organizational skills

Attention to detail

Self-motivation

Regulatory knowledge

Education

Bachelor’s degree in life sciences

Tools

MS Office

Adobe Acrobat

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

IQVIA Inc is seeking a Regulatory Operations professional to support preparation, review, and publishing of regulatory submissions and study documents for internal and external clients in the Philippines.

You will coordinate with clinical, regulatory, and publishing teams, ensure compliance with GCP/ICH guidelines, and manage electronic documents using Veeva Vault and related tools.

This is a full-time position in Pasig City.