Job Title: Publishing Specialist – Regulatory Affairs
Job Summary:
Join our dynamic Regulatory Affairs team as a Publishing Specialist and lead end-to-end publishing support for global regulatory submissions. The role involves managing complex eCTD, NeeS, and paper submissions, collaborating with cross-functional teams, and ensuring high-quality regulatory deliverables. Ideal for experienced professionals seeking to contribute to regulatory excellence in the pharmaceutical industry.
Key Responsibilities:
Manage publishing for initial IND/NDA/MAA applications and lifecycle submissions worldwide.
Collaborate with multiple departments for submission planning, preparation, and quality control.
Prepare submission-ready documents, including formatting, hyperlinking, and processing in MS Word and Adobe Acrobat.
Maintain proficiency in agency standards and evolving regulatory procedures.
Handle eCTD, NeeS/eSub, and Paper formats for global submissions.
Troubleshoot document formatting issues and resolve gaps in collaboration with client stakeholders.
Perform QC checks on published output ensuring compliance with regulatory validation criteria.
Provide training and mentorship to junior team members in submission processes.
Offer client feedback for SOP/process improvements for efficient project delivery.
Support project leads in task planning and ensure deliverable timelines are met.
Track documents, identify gaps, and communicate effectively with cross-functional teams.
Required Skills & Qualifications:
Experience: 8 to 10 years in Regulatory Affairs publishing.
Expertise in creation of outputs for eCTD, NeeS, and paper submissions.
Deep knowledge of US FDA, Health Canada (HC), and global agency submission processes.
Proven ability in handling IND, NDA, MAA, and LCM projects with tight deadlines.
Strong analytical and problem-solving skills.
Excellent MS Word and Adobe Acrobat skills; ability to troubleshoot document-level issues.
Familiarity with regulatory tools such as pharmaREADY®, Lorenz, Insight Publisher, Veeva Vault, eCTD Express, Extedo.
Effective cross-functional coordination and project execution ability.
Perks & Benefits:
Competitive salary (not specified in the description)
Opportunity to work on global regulatory submissions
Professional development and training programs
Collaborative work environment with cross-functional exposure
Access to cutting-edge publishing tools and platforms
Company Description:
A leading global life sciences organization, offering comprehensive services in regulatory affairs, pharmacovigilance, and clinical research. Known for regulatory excellence and a strong commitment to quality, innovation, and compliance in the pharmaceutical industry.
Work Mode:
On-site / Hybrid (Location not explicitly mentioned; adjust as per actual job location)
Call to Action:
Ready to advance your career in regulatory publishing? Apply now to join our expert Regulatory Affairs team and make a difference in global healthcare compliance!
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