Senior Associate - Regulatory Affairs

clinchoice; Bengaluru; On-site; INR 600,000 - 1,100,000; Full time

Job summary

ClinChoice in Bengaluru is seeking an entry-level Regulatory Publishing Associate to support electronic regulatory submissions. The role involves preparing, formatting, validating, and compiling submission-ready documents in compliance with global health authority requirements.

This position offers exposure to regulatory operations within the pharmaceutical and life sciences sector, focusing on eCTD submissions, document formatting, and lifecycle management.

Qualifications

• Bachelor's degree in Life Sciences / Pharmacy / Biotechnology preferred.
• 3-5 years of experience.
• Basic understanding of pharmaceutical regulatory environment preferred but not mandatory.
• Good knowledge of MS Office (Word, Excel, PowerPoint).
• Strong attention to detail and good written and verbal communication skills.

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.

Skills

Attention to detail

Written & verbal communication

MS Office proficiency

Regulatory publishing knowledge

Team collaboration

Education

Bachelor's degree in Life Sciences / Pharmacy / Biotechnology

Tools

eCTD tools

Veeva Vault

Lorenz DocuBridge

Job description

Job Title: Senior Associate - Regulatory Affairs

About ClinChoice

ClinChoice is a partner to the largest pharmaceutical, medical device, vaccine, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, quality-as-a-service, medical affairs, toxicology, and technology solutions 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, Canada, the United Kingdom, Italy, Poland, 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.

Job Summary

We are looking for an entry-level Regulatory Publishing Associate to support electronic regulatory submissions. The role involves preparing, formatting, validating, and compiling submission-ready documents in compliance with global health authority requirements.

This is an excellent opportunity for candidates interested in regulatory operations within the pharmaceutical / life sciences industry.

Key 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

Required Qualifications

• - Bachelor's degree (Life Sciences / Pharmacy / Biotechnology preferred)
• - 3-5 years of experience
• - 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

Preferred Skills (Good to Have)

• - Exposure to eCTD publishing concepts
• - Familiarity with publishing tools (e.g., eCTD tools, Veeva Vault, Lorenz DocuBridge, etc.)
• - Basic understanding of submission lifecycle

Key Competencies

• - High attention to detail
• - Willingness to learn publishing tools
• - Time management and ability to meet deadlines
• - Team collaboration