Aurolab, a leading name in the pharmaceutical industry, is hiring a Regulatory Submission Publisher in Madurai, Tamil Nadu. This full-time on-site role offers exposure to global regulatory submissions for agencies such as US FDA, EMA, Health Canada, and MHRA. Ideal candidates will have experience in regulatory publishing, eCTD submissions, and document management.
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As a Regulatory Submission Publisher, you will assist in compiling, formatting, publishing, and validating submissions, ensuring compliance with international regulatory standards.
Key Responsibilities
- Assist in publishing regulatory submissions (NDA, ANDA, MAA, variations, IND, DMF) in eCTD and NeeS formats.
- Ensure submission-ready documents comply with global health authority requirements and internal publishing standards.
- Format documents, add bookmarks, hyperlinks, and execute validation checks using publishing tools.
- Deliver submissions to global health authorities via electronic gateways (e.g., ESG for FDA, CESP for EMA).
- Maintain archival and version control of submission packages in regulatory systems.
- Collaborate with regulatory operations leads, submission managers, and medical writers to ensure smooth publishing workflows.
- Troubleshoot technical issues in submission files and stay updated with latest eCTD specifications and guidance.
Qualifications & Skills
- B. Pharm degree or equivalent experience in Chemistry or related discipline.
- Familiarity with regulatory publishing tools and eCTD standards.
- 3-5+ years of experience in regulatory submission publishing.
- Strong attention to detail, technical proficiency, and knowledge of global health authority regulations.
Benefits
- Competitive salary package (INR 5–7 LPA, negotiable based on experience).
- Exposure to global regulatory affairs and multi-agency submission experience.
- Opportunities for career growth and skill development in regulatory publishing.
- Work in a collaborative and supportive pharmaceutical R&D environment.
How to Apply
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