Join Sun Pharma as a Junior Submission Publisher – Regulatory Affairs

Sun Pharmaceutical Industries Ltd, a global leader in innovative medicines, is hiring a Junior Submission Publisher for its Regulatory Operations – Global Regulatory & Business Continuity team. This role offers a chance to gain international exposure to regulatory submissions (eCTD, NeeS, CTD) across markets such as the US FDA, EMA, MHRA, and Health Canada.

If you are passionate about regulatory affairs, detail-oriented, and eager to grow in a collaborative environment, this opportunity could be your next career milestone.

Key Responsibilities

As a Junior Submission Publisher at Sun Pharma, you will:

• Assist in compiling, formatting, and publishing regulatory submissions (NDA, ANDA, BLA, MAA, IND, DMF, variations, supplements).
• Prepare submission-ready documents ensuring compliance with global health authority specifications.
• Perform document formatting, bookmarking, and hyperlinking per agency requirements.
• Run validation checks using publishing tools to ensure error-free submissions.
• Support electronic submissions through global gateways (e.g., FDA ESG, EMA CESP).
• Maintain archival and version control of submission packages.
• Collaborate with regulatory operations leads, submission managers, and medical writers.
• Troubleshoot technical issues in submission files.
• Stay updated on eCTD specifications, publishing tools, and regulatory guidance.

Required Qualifications & Skills

• Education: Master’s degree (M.Pharm in Pharmaceutics, Regulatory Affairs, Pharmaceutical Sciences, or Life Sciences).
• Experience: 3–5+ years in regulatory publishing.
• Knowledge: Basic understanding of CTD/eCTD structure and global submission processes.
• Tools: Familiarity with Lorenz DocuBridge, Extedo, Liquent (preferred).
• Skills: Strong attention to detail, MS Office and Adobe Acrobat proficiency, teamwork, and effective communication.

Why Join Sun Pharma?

At Sun Pharma, employees are encouraged to “Create Your Own Sunshine.” You’ll benefit from:

• Exposure to global regulatory agencies and submission standards.
• A supportive, collaborative, and growth-focused work culture.
• Competitive salary with performance-based growth opportunities.
• Comprehensive employee well-being and benefits programs.

Job Details

• Job Title: Junior Submission Publisher
• Business Unit: Regulatory Operations – Global Regulatory & Business Continuity – Innovative Medicines
• Job Grade: Senior Executive / G11B
• Location: Mumbai (preferred) / Gurugram / Vadodara
• Experience: 3–5+ years
• Travel: Low

How to Apply

Application Link