Job Description

Description:
Responsible for publishing, reviewing, archiving, and dispatching eCTD, NeeS or paper regulatory submissions for Devices & Drugs Submissions.
Manage and lead regulatory publishing operations for global submissions.
Ensure submissions meet the global eCTD requirements and other regional formats (NeeS, paper).
Coordinate with a cross functional team including Regulatory Affairs, CMC, Quality and Clinical team to plan submission strategy and timelines.
Oversee and ensure timely publishing and dispatch of regulatory submissions using various publishing tools (e.g. Veeva Vault RIM, eCTDXpress, Extedo, Lorenz).
Perform quality control checks of published submissions to ensure technical and formatting compliance.
Should have expertise in health authority gateways for submission dispatch i.e. ESG, MHRA portal, CESP, EMA portal.
Implement and maintain publishing SOPs, work instructions, and quality standards.
Develop training programs and mentor junior team members.
Qualifications:
Bachelor's or master's degree in Life science, regulatory affairs or related field with 8 or more years' experience in regulatory operations with significant hands-on publishing experience.
Strong knowledge of global regulatory standards (eCTD, NeeS, paper) and regional authority expectations (FDA, EU, Health Canada etc.)
Strong technical skills and proficiency with publishing tools (Veeva Vault RIM, ISI Toolbox, eCTDXpress, ISI Publisher, Adobe Acrobat, ISI Writer, Excel, Microsoft word, Databases).
Strong attention to detail, organizational skills and the ability to manage multiple priorities under tight deadlines.
Candidate must be able to work in a team-oriented, fast-paced environment.
Demonstrated leadership, coaching or mentoring skills.
Excellent communication and interpersonal skills.