Sr. Regulatory Document Coordinator
Location: Bengaluru, India | Job Type: Full-Time | Hybrid | Job ID: R1515567
Company Overview
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We deliver innovative solutions that accelerate drug development and improve patient outcomes worldwide. Join a team that drives excellence in regulatory submissions and medical communications. Learn more at IQVIA Careers.
Job Description
IQVIA is seeking a Sr. Regulatory Document Coordinator to support the compilation, publishing, and quality control of regulatory submission documents. The role ensures timely delivery of high-quality dossiers for both paper and electronic submissions, including NeeS and eCTD formats, in compliance with Health Authority guidelines. This position offers hybrid working flexibility in Bengaluru and is ideal for candidates with a foundational understanding of regulatory affairs and medical writing.
Key Responsibilities
Compile, publish, and perform technical quality control for regulatory submissions under guidance from senior staff.
Support the production of clinical study report (CSR) appendices following ICH guidelines and IQVIA standard practices.
Prepare electronic submissions, including bookmarking, hyperlinking, and creating tables of contents according to Health Authority (HA) standards.
Coordinate the collection and assembly of submission components to ensure completeness and accuracy.
Interact with internal clients and provide support in communication with external stakeholders as needed.
Manage day-to-day workload for assigned tasks efficiently, prioritizing deadlines and deliverables.
Maintain awareness of industry trends, regulatory updates, and advances in medical writing, regulatory submissions, and drug development.
Adhere to company SOPs and actively participate in the implementation of new procedures.
Required Knowledge, Skills, and Abilities
Basic knowledge of clinical research regulatory requirements (GCP, ICH guidelines) and SOPs, or willingness to learn.
Strong written, verbal, and interpersonal communication skills.
Excellent organizational, time management, and multitasking abilities.
Proficient in Microsoft Office and web-based applications.
Attention to detail and accuracy; ability to maintain high-quality standards.
Ability to follow instructions independently while taking initiative.
Self-motivated, flexible, and open to learning new skills.
Minimum Education and Experience
Bachelor’s degree in life sciences or a related discipline.
Understanding of regulatory affairs and document publishing is preferred.
Prior experience in medical writing, regulatory submissions, or clinical research coordination is advantageous.
Why Join IQVIA?
Work in a global, innovative environment focused on transforming healthcare and patient outcomes.
Collaborate with cross-functional teams on high-impact projects.
Opportunities for career growth, skills development, and exposure to cutting-edge regulatory practices.
Commitment to integrity and professionalism in a supportive workplace culture.
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