Regulatory Submission Publishing Specialist

Position Title: Regulatory Submission Publishing Specialist

Work Location: Remote

Assignment Duration: 12 Months

Position Summary:

• We are seeking a highly skilled Regulatory Submission Publishing Specialist to join our Diagnostics Regulatory Affairs team.
• This role is critical to managing and optimizing the end-to-end preparation, publishing, and electronic submission of regulatory documents supporting the registration of a diverse portfolio of global diagnostic products. You will oversee compliance with global regulatory frameworks and standards, primarily focusing on US and EU markets, and leverage advanced publishing tools and electronic submission gateways to ensure timely and accurate submissions.

Key Responsibilities:

• Lead the preparation, publishing, and electronic submission of regulatory dossiers for a diverse portfolio of diagnostics products, ensuring accuracy and compliance with regulatory requirements for 510(k), PMA, BLA, IND, IDE, IVDR, and other diagnostic submission types.
• Use platforms like Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress for compiling, validating, and publishing submission packages.
• Manage submissions through electronic submission gateways including FDA CCP and ESG, Notified Body portals, and EMA Common Gateway, overseeing processing, validation, and issue resolution for uploads.
• Conduct comprehensive quality control and compliance checks on submissions, including detailed validation report review and submission quality assurance to prevent errors.
• Oversee submission lifecycle management and sequence planning to align with global regulatory timelines, product development strategies, traceability, and archiving requirements.
• Collaborate closely with cross-functional teams, including Regulatory Leads, commercial affiliates, commercial vendors, and IT platform owners to troubleshoot publishing challenges, and facilitate smooth submission processes.
• Manage and maintain regulatory document repositories and publication databases within systems such as Veeva Vault, Veeva RIM, DMS, and CMS to ensure audit readiness and data integrity.
• Apply regulatory standards (FDA, EMA, ICH) rigorously throughout the publishing and submission lifecycle, adapting to evolving guidelines and internal procedures.
• Continually communicate requirements for "submission ready" publishing to Regulatory staff, contribute to submission process improvements, automation opportunities, and best practice implementations across the regulatory submission function.
• Drive adoption of new requirements, emerging technologies, including AI and robotic process automation (RPA), to enhance publishing efficiency and accuracy.
• Support processes for new and emerging global regulatory requirements and pathways, including reliance.

Qualification & Experience:

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or related field; advanced degree preferred.
• 5+ years' experience in regulatory submission publishing for diagnostics or related life science areas.
• Experience with AI, RPA, or publishing automation tools is highly preferred.
• Strong understanding of FDA, EMA, ICH regulatory standards. Familiarity with global regulatory environments beyond US/EU.
• Excellent organizational and communication skills, with ability to handle multiple deadlines independently.
• Experience in continuous improvement and automation.
• Leadership or mentoring experience is a plus.