Senior Manager and Editor, Regulatory Submissions Strategy

About the role

Support communications on complex scientific and regulatory submissions for a Fortune 500 company with iconic brands. The Senior Manager and Editor, Regulatory Submissions Strategy will join the Regulatory Affairs Organization in Richmond, VA, working a hybrid schedule with relocation assistance provided. This role develops, writes, edits, and proofreads scientific and regulatory communications—including FDA product application submissions, presentations, and other scientific documents—while collaborating with scientists, project managers, and senior leadership to translate complex information into clear, accurate, compliant, high‑quality content. This position is not eligible for sponsorship.

Responsibilities

• Participate in development of strategy for large‑scale FDA submission documents.
• Write and edit submission documents, effectively integrating science and advocacy into clear, accurate, and compliant communications.
• Edit and proofread a range of content — including printed materials and slide presentations — to ensure clarity, accuracy, consistency, and application of required editorial style.
• Ensure timely delivery of consistent, high‑quality, accurate, and complete written materials, maintaining quality and version control across large‑scale documents.
• Manage internal stakeholder relationships with scientists, senior management, project managers, and science authors to deliver the best written product.
• Supervise and coordinate contract editorial resources as needed to meet submission timelines and quality standards.

Requirements

• Bachelor’s degree in a regulatory, scientific, legal, or related field required; advanced degree preferred.
• 8+ years of relevant experience writing or editing business, public affairs, regulatory, scientific, or legal documents.
• Working knowledge of FDA processes and requirements; direct experience developing FDA submissions strongly preferred.