Manager, Regulatory Operations and Publishing

For our client, we are seeking a Manager, Regulatory Operations and Publishing to join the team of a leader in the Pharmaceuticals & Biotech space. This role will oversee day-to-day regulatory submission operations, helping ensure documents are formatted, published, and quality-checked to meet submission standards. The manager will partner with authoring teams, submission vendors, and internal stakeholders to keep deliverables moving on schedule. Strong attention to detail and a deep understanding of electronic submission processes will be essential to supporting compliant, submission-ready packages. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $134,505 – $162,988 annually Responsibilities Manage day-to-day regulatory submission operations activities Format complex documents to optimize PDF rendering Generate submission-ready PDFs in compliance with regulations Perform technical QC of submission documents Manage submission execution activities and deliverable tracking Coordinate with external submission vendors for timely delivery Support authoring teams with document template usage Qualifications Bachelor's degree with 4+ years of Regulatory Operations experience Experience with Accenture StartingPoint Templates and Veeva RIM preferred Demonstrated expertise in Microsoft Word formatting and PDF publishing Strong understanding of eCTD submission structure and standards Experience performing technical quality control of regulatory submissions Highly detail-oriented with strong organizational skills Excellent communication and interpersonal skills Benefits Health coverage including medical, pharmacy, dental, and vision care Wellbeing support programs including Employee Assistance Programs (EAP) Financial well-being benefits like 401(k) and life insurance Flexible paid time off, including unlimited time off with manager approval Additional time off options for personal, medical, and caregiving needs Participation in an annual global shutdown between Christmas and New Year's Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.