ClinChoice is inviting applications for the position of Associate – Regulatory Affairs (Publishing) in Chennai, India. This is an excellent opportunity for B.Pharm, Life Sciences, and Biotechnology freshers (0–1 year experience) looking to start a career in Regulatory Affairs Publishing and eCTD submissions within a global CRO environment.
With increasing global demand for Regulatory Affairs professionals, eCTD publishing associates, and regulatory submission specialists, this role offers foundational exposure to electronic regulatory submissions, lifecycle management, and global health authority compliance.
📌 Job Overview
- Position: Associate – Regulatory Affairs (Publishing)
- Location: Chennai, India
- Employment Type: Contract
- Work Model: Office-based
- Experience: 0–1 Year (Freshers may apply)
- Industry: Regulatory Affairs, eCTD Publishing, Pharma CRO
This Regulatory Affairs Publishing job in Chennai focuses on supporting eCTD and non-eCTD submissions, document formatting, validation checks, and lifecycle management activities.
🔬 Key Responsibilities – Regulatory Affairs Publishing
Selected candidates will work closely with global regulatory teams and support electronic submissions. Responsibilities include:
- Support preparation of eCTD and non-eCTD submissions
- Perform document formatting, bookmarking, hyperlinking, 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 submission lifecycle management (new, replace, delete sequences)
- Coordinate with internal teams for submission readiness
- Prepare, format, validate, and compile submission-ready documents
- Ensure compliance with global health authority requirements (USFDA, EMA, etc.)
This role provides strong exposure to Regulatory Affairs Publishing tools such as Veeva Vault, Lorenz DocuBridge, and eCTD software platforms.
🎓 Qualifications & Skills Required
Candidates applying for this Regulatory Affairs Associate job should have:
- Bachelor’s degree in Life Sciences / Pharmacy / Biotechnology
- 0–1 year experience (Freshers eligible)
- Basic understanding of pharmaceutical regulatory environment (preferred)
- Knowledge of MS Office (Word, Excel, PowerPoint)
- Exposure to eCTD publishing concepts
- Familiarity with publishing tools (Veeva Vault, Lorenz DocuBridge, etc.) – desirable
- Understanding of submission lifecycle
- High attention to detail and accuracy
- Strong written and verbal communication skills
- Ability to manage deadlines and work collaboratively
Fresh graduates looking for Regulatory Affairs jobs in Chennai for freshers can apply confidently.
🌍 About ClinChoice
Established in 1995, ClinChoice is a global CRO providing expertise in:
- Clinical Operations
- Biometrics
- Regulatory Affairs
- Pharmacovigilance
- Medical Affairs
- Toxicology
With delivery centers across the US, UK, India, China, Japan, and other global markets, ClinChoice supports pharmaceutical, medical device, and consumer healthcare companies in accelerating clinical trials and regulatory approvals.
💼 Why Apply for This Regulatory Affairs Job?
- Entry-level opportunity in Regulatory Affairs Publishing
- Exposure to global regulatory submission standards
- Hands-on experience in eCTD lifecycle management
- Career pathway toward Regulatory Affairs Specialist roles
- Opportunity to work in a global CRO environment
- Strong learning exposure in electronic submissions
For candidates aiming to build a career in Regulatory Affairs, regulatory publishing, or submission management, this role offers a structured starting point.
📍 Job Location
Chennai, Tamil Nadu, India
(Office-based work model)
💰 Expected Salary Range
For entry-level Regulatory Affairs Publishing roles in Chennai, the estimated salary range is:
₹2.8 – ₹4.2 LPA (CTC)
(Salary may vary based on skills, interview performance, and company policies.)
📅 How to Apply
