Pharmaceutical Jobs in Mumbai: Sun Pharmaceutical Industries Ltd is hiring a Junior Submission Publisher – Apply Now
If you are looking for exciting Pharmaceutical Jobs in Mumbai, Sun Pharmaceutical Industries Ltd is hiring a Junior Submission Publisher in Mumbai, Gurugram, and Vadodara. This role provides hands-on exposure to global regulatory submissions, including eCTD and non-eCTD formats, for agencies such as US FDA, EMA, and Health Canada. Join Sun Pharma to enhance your expertise in regulatory publishing while contributing to innovative medicines that impact patient lives worldwide.
About the Company:
Sun Pharma is India’s largest pharmaceutical company and the world’s fourth-largest specialty generic company. With a presence in over 100 countries, Sun Pharma delivers high-quality medicines across more than 40 therapeutic areas. The company is committed to innovation, regulatory compliance, and global quality standards, empowering professionals to grow and contribute to improving patient lives worldwide.
Job Details:
- Job title: Junior Submission Publisher
- Location: Mumbai (preferred) / Gurugram / Vadodara
- Job Type: Full-time
- Business Unit: Regulatory Operations – Global Regulatory & Business Continuity – Innovative Medicines
- Job Grade: Senior Executive / G11B
Key Responsibilities:
- Assist in publishing regulatory submissions (NDA, ANDA, BLA, MAA, variations, supplements, IND, DMF, etc.) in eCTD and NeeS formats.
- Ensure submission-ready documents comply with global health authority specifications and internal standards.
- Perform document formatting, bookmarking, and hyperlinking per agency requirements.
- Execute validation checks to ensure submissions are compliant.
- Deliver submissions electronically through gateways (e.g., ESG for FDA, CESP for EMA).
- Maintain archival and version control of submission packages in regulatory systems.
- Collaborate with regulatory leads, submission managers, and medical writers for smooth workflows.
- Support troubleshooting and resolution of technical issues in submission files.
- Stay updated on changes in eCTD specifications, guidance, and publishing tools.
Qualifications & Skills
- Master’s degree in Pharmacy (M.Pharm) or Life Sciences.
- Basic knowledge of CTD/eCTD structure and global submission requirements.
- Familiarity with publishing tools (Lorenz DocuBridge, Extedo, Liquent, etc.) is desirable.
- Strong attention to detail and ability to meet tight deadlines.
- Good communication and team collaboration skills.
- Proficiency in MS Office and Adobe Acrobat for document handling.
Experience:
3–5+ years in regulatory publishing
