Global Regulatory Submissions Lead

Pharmaceutical Company; United States; On-site; USD 70,000 - 110,000; Full time

Job summary

Pharmaceutical Company seeks a Regulatory Submission Publishing Specialist to join the Diagnostics Regulatory Affairs team. You will manage end-to-end publishing and electronic submissions for a global diagnostic product portfolio, focusing on FDA/EMA pathways and ensuring compliance across ICH guidelines.

You will leverage platforms like Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress, coordinating with Regulatory Leads, commercial affiliates, and IT to optimize submissions and data

Qualifications

• Bachelor’s degree in Life Sciences, Regulatory Science, Quality Assurance, or related field.
• 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.
• Leadership or mentoring experience is a plus.

Responsibilities

• Lead preparation, publishing, and electronic submission of regulatory dossiers for diagnostics products in US/EU markets.
• Oversee compliance with regulatory requirements for 510(k), PMA, BLA, IND, IDE, IVDR, and other submissions.
• Utilize platforms like Veeva Vault, LORENZ docuBridge FIVE, or eCTD Xpress for packaging and publishing.
• Manage submissions through FDA CCP/ESG, Notified Body portals, and EMA Gateway, including validation and issue resolution.
• Perform quality control and compliance checks, including validation report reviews and QA for submissions.
• Coordinate submission lifecycle and sequencing to align with timelines, archiving, and traceability.
• Collaborate with Regulatory Leads, commercial teams, vendors, and IT to troubleshoot publishing challenges.
• Maintain regulatory document repositories and publication databases in Veeva Vault, Veeva RIM, DMS, CMS for audit readiness.
• Apply FDA, EMA, ICH standards to publishing workflows and adapt to evolving guidelines.
• Identify automation opportunities and drive adoption of new requirements and technologies.

Skills

Regulatory publishing

AI/RPA/publishing automation

Cross-functional collaboration

Attention to detail

Regulatory standards knowledge

Education

Bachelor’s degree in Life Sciences, Regulatory Science, QA, or related field

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

Job description

Pharmaceutical Company seeks a Regulatory Submission Publishing Specialist to join the Diagnostics Regulatory Affairs team. You will manage end-to-end publishing and electronic submissions for a global diagnostic product portfolio, focusing on FDA/EMA pathways and ensuring compliance across ICH guidelines.

You will leverage platforms like Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress, coordinating with Regulatory Leads, commercial affiliates, and IT to optimize submissions and data