Regulatory Affairs Officer

IQVIA; Manila; Hybrid; PHP 500,000 - 700,000; Full time

Job summary

IQVIA is seeking a Regulatory Publishing Specialist to support peer publishers and eCTD leads in preparing study reports, submissions, and related documents for internal or external clients. You will perform quality control reviews, collect appendices, and assist with document publishing.

Responsibilities include preparing and reviewing regulatory submission documents (NDAs, INDs, 510(k)s, annual reports, PSRs, variations, renewals).

Qualifications

• Bachelor’s degree in a life science-related discipline; 3–7 years industry experience preferred.
• Basic knowledge of regulatory requirements (GCP, ICH) and SOPs, or willingness to learn.
• Strong communication skills (verbal, written, aural).
• Strong organizational and time management skills.
• Proficient in Microsoft Office and web-based applications.
• Attentive to detail and accuracy; able to maintain quality standards.
• Ability to follow instructions, work independently and use initiative.
• Proven ability to multi-task and manage competing priorities and deadlines.
• Willingness and aptitude to learn new skills; self-motivated and flexible.

Responsibilities

• Prepare and/or review regulatory submission documents to support clinical and marketing authorization activities.
• Create, assemble and publish major and routine global submissions (NDAs, INDs, 510(k)s, Annual Reports, PSRs, Supplements, Variations, Renewals).
• Support regulatory affairs in coordination, preparation, and submission of submissions.
• Handle pre-publishing (bookmarks/hyperlinks), compilation, post-publishing validation, and lifecycle management submissions.
• Track project timelines, coordinate with senior staff, and manage day-to-day workload.
• Perform QC to ensure integrity and quality of each published unit.
• Plan, prepare, track, and archive regulatory documents in paper and electronic formats.
• Maintain FDA/Regulatory correspondence and ensure timely filing in document management systems.
• Collaborate with clinical, nonclinical, CMC, regulatory to ensure compliance with style guides.
• Participate in project teams and communicate confidently; stay updated on regulations governing controlled documents.

Skills

Communication

Organization

Time management

Attention to detail

Independent work

Learning mindset

Multi-tasking

Self-motivation

Education

Bachelor's degree in life sciences

Tools

MS Office

Adobe Acrobat

Electronic Document Management Systems

Veeva Vault

RIM Smart

Insight

eCTDXpress

Extedo

Lorenz

Job description

Job Overview

Supports peer Publishers/Publishing Leads and eCTD Lead in the preparation of study reports, submissions, or other documents for either internal IQVIA customers or external clients by providing quality control review, collecting appendices for documents, document preparation and publishing, and providing general assistance with document compilation.

Responsibilities:

• Under general supervision, Prepares and/or reviews regulatory submissions documents to support clinical trial and marketing authorization activities for either internal and/or external clients. Provides regulatory support for assigned projects.
• Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
• Support Regulatory Affairs personnel in the coordination, preparation, and submission of all above submissions.
• Responsible for the pre-publishing (Bookmarks and Hyperlinks), compilation, post publishing, Validation of Regulatory submissions and lifecycle management submissions.
• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.
• Perform QC process to ensure the integrity and quality of each published unit.
• Planning, preparing, tracking, and archiving regulatory documents and submissions in paper and electronic formats.
• Responsible for maintenance of all Regulatory and FDA correspondence (distributing, filing into electronic document management system) within specified time frames.
• Liaise with functional source areas (clinical, nonclinical, CMC, regulatory) to ensure documents are compliant with authoring style guide. “Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications”.
• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.
• Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the US FDA, EMEA and ICH.
• May represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Keep close interaction with authoring community to track availability of deliverables.
• Technical knowledge of electronic publishing systems and software (Veeva Vault, RIM Smart, Insight, eCTDXpress, Extedo, Lorenz)
• May prepare and deliver trainings, as appropriate.
• Proficiency with MS-Office Suite and Adobe Acrobat applications, Knowledge of Electronic Document Management Systems.
• Responsible in solving day to day queries of the team members.
• Self-starter with superior time management skills, and ability to work independently or in teams
• Performs other tasks or assignments, as delegated by Regulatory management.

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. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, standard operating procedures (SOPs) or the ability and willingness to gain this knowledge.
• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.