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

Role Description The Project Manager/Technical Assistance Provider (PM/TAP) will work with project communities and utilities to provide guidance, training, and technical assistance to improve or develop water, wastewater, solid waste systems, and other related programs or services. Primary responsibilities include: - Project management - Providing technical guidance - Planning and delivering training - Performing outreach and networking - Program development - Performing research and analysis - General administrative duties - Contract management/mediation - Assisting with codes/ordinances/grants and grants management - Promoting system operational standards to meet regulatory compliance - Identifying cost savings and promoting system longevity/sustainment - Assisting communities with the drafting of by-laws, policies, procedures, and rate setting Qualifications - Bachelor’s Degree preferred, but not required (Qualifying experience is equally important to education preferences) - Any combination of applicable experience in environmental policy management, water, wastewater, or solid waste facilities development or planning - Advanced personal computer skills are critical to success; familiarity with Microsoft Office, Outlook, Word, Excel, and Adobe Pro is required - Effective written communication skills - Financial and Managerial certifications, training or experience is helpful - Certain positions may require water and/or wastewater operator certification Requirements - Knowledge of project management - Understanding of program development techniques - Familiarity with federal, state, tribal, and local government agencies, programs, issues, and regulations related to water, wastewater, and solid waste programs and facilities - Awareness of non-profit, tribal, and local agency and rural community dynamics - General record-keeping practices - Basic financial fundamentals for communities - Knowledge of small rural community issues and challenges - Ability to communicate, facilitate, mediate, and manage meetings - Effective oral communication skills - Ability to write and present materials - Capability to perform thorough research and analysis - Ability to develop, deliver, and report training - Multi-tasking skills to organize and handle multiple priorities simultaneously - Willingness to travel several days of the month, up to fifteen days, including some overnight stays - Self-disciplined to work independently and effectively - Ability to respond to client needs in a variety of situations - Effective project and time management skills - Self-motivated - Effective networking skills - Ability to meet all deadlines effectively and accurately Benefits - Health, life, dental, vision, and disability insurance - Paid time off - Federally recognized holidays - Retirement programs - Travel and per diem reimbursement at established agency rates Special Requirements - Must possess a valid US driver’s license - Must have dependable transportation available at all times; travel is a critical part of this position - Must have proof of auto insurance - Must have access to reliable high-speed internet from home office - Must have reliable phone service from home office (landline and/or cell) - Some outdoor activity may be required at times Physical Requirements - Must be able to communicate effectively in English, including reading, writing, and comprehending information - Must be able to frequently observe and interpret digital and printed materials - Must be able to move within an office environment and remain in a stationary position to operate a computer/office equipment for extended periods up to 8+ hours per day with reasonable breaks - Must be able to frequently travel by various modes of transportation for business-related activities, which may occasionally involve being in transit for up to 8 hours in a day; some overnight stays may be necessary - Must be able to move and transport items such as files, office supplies, training materials, a laptop/computer, or a projector, weighing up to 55 pounds