Regulatory Submission Publishing Specialist

We are seeking an experienced Regulatory Submission Publishing Specialist to support our Diagnostics Regulatory Affairs team. This role will manage the preparation, publishing, quality review, and electronic submission of regulatory dossiers for global diagnostic products. The ideal candidate will have hands-on eCTD publishing experience, strong knowledge of FDA and EMA requirements, and experience using regulatory publishing platforms and electronic submission gateways.

Key Responsibilities

• Prepare, publish, validate, and electronically submit regulatory dossiers for diagnostic products across global markets.
• Support regulatory submissions including FDA 510(k), PMA, BLA, IND, IDE, IVDR, and other applicable submission types.
• Use publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress to compile and validate submission packages.
• Manage electronic submissions through FDA CCP/ESG, EMA Common Gateway, and Notified Body portals.
• Perform quality control checks, review validation reports, resolve publishing errors, and ensure submission accuracy.
• Manage submission sequences, timelines, document traceability, and regulatory archiving.
• Maintain regulatory document repositories and publishing records using systems such as Veeva Vault, Veeva RIM, DMS, and CMS.
• Collaborate with Regulatory Affairs, Quality, IT, and external publishing vendors to resolve submission issues and meet deadlines.
• Support continuous improvement initiatives, publishing automation, and emerging technologies, including AI and robotic process automation (RPA).

Required Qualifications

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field; an advanced degree is preferred.
• 5 years of experience in regulatory submission publishing within diagnostics or related life sciences industries.
• Strong understanding of FDA, EMA, and ICH regulatory requirements.
• Hands-on experience with eCTD publishing, dossier compilation, validation, and submission quality control.
• Experience with regulatory publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress.
• Familiarity with electronic submission gateways and global regulatory submission processes.
• Excellent organizational, communication, and stakeholder management skills.

Preferred Qualifications

• Experience with AI, RPA, or regulatory publishing automation tools.
• Knowledge of global regulatory requirements beyond the US and EU.
• Experience mentoring colleagues or improving regulatory publishing processes.

Work Environment and Culture

This is a remote role requiring independent execution, attention to detail, and collaboration with cross-functional teams across multiple geographies. The team values accountability, continuous improvement, innovation, and high-quality regulatory compliance.