• Create "High-Floor" Content: Write highly technical blog posts, landing pages, email sequences, and ads that respect the reader's intelligence, featuring code, architectural diagrams, and honest discussions of production tradeoffs • Drive the Narrative: Translate complex distributed systems concepts like Durable Execution, idempotency, and compensation logic into opinionated content that speaks peer-to-peer with engineers • Customer Storytelling: Produce developer-focused case studies and customer co-marketing content that highlight real-world use cases • Collaborate with SMEs: Work with engineering subject matter experts and customers to deeply understand systems, workflows, and design decisions • Own the Content Lifecycle: Take content from research and interviews through drafting, iteration, and publication • Develop Your Craft: Refine your technical writing skills and deepen your understanding of distributed systems concepts

Role Description Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements. This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding. Main Responsibilities: - Author, review, and finalize high-quality CMC sections (Module 2.3 and Module 3) for Phase 3 and Marketing Authorization Applications - Prepare briefing documents and responses to Health Authority questions as required - Collaborate with CMC technical teams (process development, formulation, analytical, manufacturing) to collect and interpret data - Ensure alignment of all documentation with global regulatory requirements (ICH, FDA, EMA) - Develop, maintain, and continuously improve CMC regulatory dossier templates in line with evolving guidelines - Manage submission workflows within the electronic document management system (eCTD environment) - Ensure consistency, accuracy, and scientific integrity of all regulatory narratives - Manage timelines across multiple projects and proactively communicate risks - Provide guidance and support to internal stakeholders when needed Qualifications - Minimum 10 years of experience in CMC within the pharmaceutical industry and CMC regulatory technical writing - Excellent writing, editing, and organizational skills - Strong understanding of regulatory requirements and guidelines (ICH, FDA, EMA, etc.) - Ability to work collaboratively in a fast-paced environment - Degree in Pharmacy or a relevant scientific field (Chemistry, Biology, or equivalent) - Fluent in written and spoken English Benefits - Excelling with care means benefiting from an environment that values your natural talents - Pushes boundaries with audacity - Nurtures your potential, allowing you to contribute fully to our shared mission

• Produce and maintain high-quality documentation, including user guides, SOPs, program communications, and social media content. • Write and edit technical documents with clarity, accuracy, and audience-appropriate structure. • Edit and format technical and program documentation in Word and PowerPoint. • Serve as a senior editor to ensure consistency across internal and external training materials. • Conduct quality reviews to ensure proper grammar, punctuation, and style. • Integrate multiple stakeholder inputs into polished, client-ready deliverables. • Develop client training aids such as video scripts, presentation materials, and social media content. • Learn complex technical concepts and communicate them in simple, engaging ways. • Collaborate with SMEs and internal authors to refine documentation and provide recommendations for improvement. • Gather and synthesize stakeholder feedback to enhance usability and inform future investments. • Support Agile team workflows and SDLC-aligned documentation needs. • Perform additional duties as assigned by the manager.

• Edit and refine complex technical reports, proposals, and project documents • Apply expert-level Microsoft Word skills for advanced formatting • Leverage Microsoft 365 tools to manage document workflows • Oversee comprehensive digital and physical filing systems • Coordinate with project managers, scientists, engineers, and stakeholders • Support document archiving and retrieval processes • Mentor and provide guidance to junior technical editors