Regulatory Content Strategist (Senior Medical Writer) - Remote Options Available
Location: Flexible / Global
Department: Regulatory Data & Content
Employment Type: Full-Time
About the Opportunity
We are seeking an experienced Regulatory Content Strategist to join a dynamic, forward-thinking regulatory organization committed to accelerating scientific innovation and improving global patient outcomes. This role sits within the Regulatory Data & Content function, which plays a critical part in shaping and executing content and data strategy for regulatory submissions across the product lifecycle.
As a Regulatory Content Strategist, you will lead the development, interpretation, and delivery of high-quality regulatory content—including major clinical and safety documentation—ensuring alignment with global health authority expectations. You will guide cross-functional teams, influence submission strategy, and drive innovation in content creation, reuse, and automation.
What You Will Do
*Lead content strategy for global regulatory submissions, overseeing the development, integration, and delivery of key submission components (e.g., Clinical Dossiers, Safety Reports).
*Develop content plans and timelines, ensuring alignment with broader project objectives and milestones.
*Review and refine regulatory documents for clarity, scientific accuracy, coherence, and adherence to internal and external standards.
*Resolve cross-functional content issues and ensure alignment of messaging and data interpretation.
*Participate strategically in cross-functional teams, contributing to best practices, operational excellence, and continuous improvement initiatives.
*Partner with key stakeholders across the portfolio to shape regulatory strategy and contribute to business-critical initiatives.
*Maintain up-to-date knowledge of evolving regulatory, scientific, and therapeutic-area trends.
*Mentor junior team members, sharing expertise in regulatory writing and content leadership.
Who You Are
*Degree in Life Sciences or related field, plus 5+ years of relevant industry experience, with demonstrated independent project leadership.
*Strong knowledge of global and regional regulatory frameworks, including GxP, GCP, ICH, ISO, MDR/IVDR; understanding of GVP, GCP, and data integrity principles.
*Demonstrated expertise in clinical, safety, and/or device regulatory documentation from early development through post-marketing.
*Skilled at analyzing and synthesizing complex data across scientific disciplines.
*Proven ability to drive outcomes in global regulatory filings through effective collaboration in matrixed environments.
*Advanced competency with G Suite, Microsoft Office, Adobe Acrobat, and Veeva Vault.
*Excellent communication skills, detail-oriented, adaptable, and eager to learn.
*Fluency in English (written and verbal).
Why Join
*Contribute to high-impact submissions shaping global patient access to innovative therapies.
*Work in a flexible, fast-moving, and collaborative regulatory environment.
*Influence next-generation systems, tools, and content automation efforts.
*Grow your career in a supportive, science-driven organization dedicated to patient well-being.