Regulatory Submission Publishing Specialist

Our client, a Biotech company, is looking for a Regulatory Submission Publishing Specialist for their Remote location.

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.

Requirements:

• 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.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities