Associate - Regulatory Affairs (Publishing)

Roles & Responsibilities
• Support preparation of eCTD and non-eCTD regulatory submissions
• Perform document formatting, bookmarking, hyperlinking, and PDF optimization
• Assist in submission compilation and electronic publishing activities
• Conduct technical validation checks prior to submission dispatch
• Maintain submission trackers and documentation logs
• Ensure accurate metadata and correct document placement within eCTD structure
• Support submission lifecycle management (new, replace, delete sequences)
• Coordinate with internal regulatory teams for submission readiness
• Prepare, format, validate, and compile submission-ready documents
• Ensure compliance with global health authority requirements (USFDA, EMA, etc.)
• Work with publishing tools such as Veeva Vault, Lorenz DocuBridge, and other eCTD platforms

Qualification
• Bachelor of Pharmacy, Master of Pharmacy
• Bachelor’s degree in Life Sciences / Biotechnology

Experience
• 0–1 year of experience
• Freshers eligible
• Basic understanding of pharmaceutical regulatory environment preferred

Skills
• Knowledge of MS Office (Word, Excel, PowerPoint)
• Understanding of eCTD publishing concepts
• Familiarity with publishing tools (Veeva Vault, Lorenz DocuBridge) – desirable
• Basic knowledge of submission lifecycle management
• High attention to detail and accuracy
• Strong written and verbal communication skills
• Ability to manage deadlines and collaborate with cross-functional teams

About the Company
ClinChoice is a global Contract Research Organization (CRO) providing clinical, regulatory, and consulting services to pharmaceutical, biotechnology, and medical device companies worldwide, supporting compliant and efficient global submissions.