Senior Regulatory Document Coordinator
Company: IQVIA
Location: Bengaluru, India
Work Mode: Hybrid
Job Type: Full-Time
Job ID: R1529322
Experience Required: Typically 2–5 years of experience in regulatory publishing, regulatory affairs support, or clinical research documentation
Education: Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline
About IQVIA
IQVIA is a global leader in clinical research services, healthcare analytics, and commercial insights for the life sciences industry. By combining advanced analytics, technology solutions, and deep therapeutic expertise, IQVIA supports pharmaceutical and biotechnology companies in accelerating drug development and improving healthcare outcomes worldwide.
Job Overview
IQVIA is seeking a Senior Regulatory Document Coordinator to support regulatory submission preparation and publishing activities. This role involves coordinating the compilation, formatting, quality control, and electronic publishing of regulatory submission dossiers for global health authorities.
The position requires expertise in regulatory publishing standards such as eCTD and NeeS, along with strong attention to detail to ensure regulatory documents meet international submission requirements.
Key Responsibilities
Regulatory Submission Publishing and Compilation
Support the compilation, publishing, and technical quality control of regulatory submission documents.
Assist in preparing high-quality regulatory dossiers for submission to global health authorities.
Manage the collection, organization, and assembly of regulatory submission components.
Electronic Publishing and Submission Management
Prepare electronic regulatory submissions using formats such as eCTD and NeeS.
Perform bookmarking, hyperlinking, and creation of electronic tables of contents in accordance with regulatory guidelines.
Ensure submission packages meet technical requirements defined by regulatory authorities.
Regulatory Documentation and Clinical Study Support
Assist in collecting and organizing Clinical Study Report (CSR) appendices in accordance with ICH guidelines and company procedures.
Work closely with medical writers and regulatory teams during CSR preparation and submission processes.
Quality Control and Compliance
Conduct technical quality checks on submission documents to ensure accuracy, formatting consistency, and compliance with regulatory standards.
Maintain adherence to company Standard Operating Procedures (SOPs) and regulatory documentation standards.
Stakeholder Collaboration
Communicate with internal project teams and regulatory stakeholders to coordinate submission activities.
Support senior regulatory staff in managing submission timelines and deliverables.
Handle limited external interactions under the guidance of senior regulatory professionals.
Workload and Project Management
Manage assigned tasks and day-to-day workload effectively while meeting submission deadlines.
Support multiple regulatory projects simultaneously while maintaining high quality standards.
Required Skills and Competencies
Basic understanding of clinical research regulations and guidelines, including Good Clinical Practice (GCP) and ICH guidelines.
Knowledge of regulatory publishing processes and submission formats such as eCTD and NeeS.
Strong communication skills, both written and verbal.
Excellent organizational and time management skills.
Proficiency in Microsoft Office tools and web-based documentation platforms.
Strong attention to detail with a focus on maintaining documentation accuracy and quality.
Ability to work independently while managing multiple priorities and deadlines.
Professional Skills
Strong problem-solving and analytical capabilities.
Ability to follow structured regulatory processes and guidelines.
Self-motivated with a willingness to learn new regulatory systems and technologies.
Ability to work collaboratively in cross-functional clinical research teams.
About the Organization
IQVIA provides advanced analytics, technology solutions, and contract research services to the life sciences and healthcare industries. The company connects data, science, and technology to accelerate the development and commercialization of innovative medical treatments while improving patient outcomes worldwide.
Equal Opportunity and Hiring Integrity
IQVIA maintains a strict commitment to integrity and transparency throughout the recruitment process. All candidates are expected to provide accurate and truthful information during the hiring process. Any misrepresentation or false information may lead to disqualification or termination in accordance with applicable laws.
IQVIA is committed to equal employment opportunities and considers all qualified applicants without discrimination based on race, gender, religion, disability, age, or other protected characteristics.
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