Together We Innovate. Together We Change.

Support communications on complex scientific and regulatory submissions for a Fortune 500 company with some of the most iconic brands in its industry! Have a bachelor's degree with 8+ years’ experience writing or editing business, public affairs, regulatory, scientific, or legal documents? If so, we want to speak with you!

We are actively recruiting a Senior Manager and Editor, Regulatory Submissions Strategy to join our Regulatory Affairs Organization in Richmond, VA. with a Hybrid work schedule, relocation benefits will be provided.

The Senior Manager develops, writes, edits, and proofreads scientific and regulatory communications, including FDA product application submissions, presentations, and other scientific documents. Working closely with scientists, project managers, and senior leadership, this role ensures complex scientific information is translated into clear, accurate, compliant, and high-quality content while maintaining editorial standards and integrating scientific and advocacy objectives across key regulatory submissions.

What you’ll be doing:

• 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. 

We want you to have:

• 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.
• Advanced written and editorial skills, with exceptional attention to detail and a strong command of grammar, style, and usage.
• Demonstrated ability to synthesize complex scientific and technical information using excellent critical-thinking skills.
• Proven ability to influence without authority and to collaborate effectively across broad and diverse stakeholder groups.
• Excellent interpersonal, analytical, and critical-thinking skills.
• Strong project management and organizational skills, with a proven ability to manage competing priorities and consistently meet timelines.
• Proficiency with Microsoft Word, PowerPoint, and Sharepoint; familiarity with electronic document management and regulatory publishing systems (e.g., eTTD) preferred.
• Demonstrated ability to use Cowork and other AI tools to increase efficiency.
• RIM tool experience preferred.