Technical Regulatory Affairs Writer

Essential Functions

• Coordinate regulatory submission projects and support the preparation, compilation, review, and tracking of regulatory documentation.
• Manage assigned regulatory projects, including planning, timelines, deliverables, and cross-functional communication to support successful submissions and product lifecycle activities.
• Maintain project tracking systems and databases to monitor departmental deliverables, milestones, and key performance metrics.
• Facilitate incoming regulatory requests by logging, prioritizing, assigning, and tracking activities through completion.
• Support the preparation and organization of submission content, ensuring consistency, completeness, and adherence to internal procedures.
• Collaborate with Regulatory Affairs and cross-functional stakeholders to identify project risks, resolve resource constraints, and maintain project schedules.
• Assist with document management activities, including version control, archival, and maintenance of regulatory records.
• Utilize electronic document management and submission tools to improve efficiency and streamline submission processes.
• Support continuous improvement initiatives related to regulatory operations, documentation practices, and workflow management.
• Contribute to departmental objectives through effective project coordination, communication, and execution of assigned responsibilities.
• Provide support for internal audits, inspections, and compliance-related activities as needed.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in Life Sciences, Technical Writing, Regulatory Affairs, Project Management, or a related field preferred.
• Minimum 3 years of experience supporting regulatory affairs, regulatory operations, technical documentation, submission publishing, or related activities within a regulated industry.
• Minimum 3 years of project coordination or project management experience.
• Experience managing multiple projects and competing priorities in a fast-paced environment.
• Familiarity with regulatory submissions, document control systems, electronic publishing tools, or content management systems.
• Strong organizational skills with demonstrated attention to detail and commitment to documentation quality.
• Excellent written, verbal, and interpersonal communication skills.
• Ability to work effectively with cross-functional teams and stakeholders at multiple organizational levels.
• Strong problem-solving, decision-making, and project coordination skills.
• Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and project tracking tools.