Sr Reg Doc Coord

Roles & Responsibilities:

• Support compilation, publishing, and technical quality control of regulatory submissions
• Assist in preparation of high-quality dossiers including collection of components, publishing/assembly, QC review, and delivery in paper and electronic formats (NeeS, eCTD, etc.)
• Perform bookmarking, hyperlinking, and table of contents creation as per Health Authority (HA) guidelines
• Assist in collection of CSR appendices in accordance with ICH guidelines and company standards, under guidance of lead medical writer
• Interact with internal stakeholders and coordinate with external clients as directed by senior staff
• Manage day-to-day workload for assigned tasks in collaboration with senior team members
• Stay updated with trends and developments in drug development, medical writing, and regulatory submissions
• Ensure compliance with company SOPs and participate in implementation of new SOPs

Qualification:

• Bachelor’s degree in Life Sciences or related discipline
• Basic understanding of Regulatory Affairs and Publishing preferred

Experience:

• Freshers or candidates with relevant academic/project exposure to regulatory publishing can apply
• Understanding of GCP, ICH guidelines, and regulatory submission processes preferred

Skills:

• Knowledge of clinical research regulatory requirements (GCP, ICH guidelines)
• Strong verbal and written communication skills
• Good organizational and time management abilities
• Proficiency in Microsoft Office and web-based tools
• High attention to detail and quality standards
• Ability to follow guidelines and work independently
• Multi-tasking and deadline management skills
• Self-motivated, flexible, and quick learner

About the Organization:

IQVIA is a leading global provider of clinical research services, healthcare intelligence, and commercial insights for the life sciences industry. The company accelerates medical innovation and improves patient outcomes worldwide through data-driven solutions and regulatory expertise.