Associate - Regulatory Affairs (Publishing)

Job Title: Associate – Regulatory Affairs (Publishing)
Employment Type: Contract
Location: Chennai, India
Work Type: Office-based
Experience: 0–1 year

About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Primary Responsibilities
• Support preparation of eCTD and non-eCTD submissions.
• Perform document formatting, hyperlinking, bookmarking, and PDF optimization.
• Assist in submission compilation and publishing activities.
• Conduct technical validation checks prior to submission.
• Maintain submission trackers and documentation logs.
• Ensure metadata accuracy and correct document placement.
• Support lifecycle management activities (new, replace, delete sequences).
• Coordinate with internal teams for submission readiness.

Secondary Responsibilities
• Support electronic regulatory submissions.
• Prepare, format, validate, and compile submission-ready documents in compliance with global health authority requirements.

Candidate’s Profile
• Bachelor’s degree (Life Sciences / Pharmacy / Biotechnology preferred).
• 0–1 year experience (freshers may apply).
• Basic understanding of pharmaceutical regulatory environment (preferred but not mandatory).
• Good knowledge of MS Office (Word, Excel, PowerPoint).
• Strong attention to detail.
• Good written and verbal communication skills.
• Exposure to eCTD publishing concepts.
• Familiarity with publishing tools (e.g., eCTD tools, Veeva Vault, Lorenz DocuBridge, etc.).
• Basic understanding of submission lifecycle.
• High attention to detail.
• Willingness to learn publishing tools.
• Time management and ability to meet deadlines.
• Team collaboration.