Technical Regulatory Affairs Writer

Harba; St. Louis (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Harba in the United States is seeking a Regulatory Submissions Coordinator/Manager to lead and support regulatory documentation, ensure accurate compilation, and track submission activities across product lifecycles.

The role requires strong project coordination, attention to detail, and excellent written and verbal communication to collaborate with cross-functional teams, audits, and external partners in a fast-paced regulatory environment.

Qualifications

• Bachelor's degree in Life Sciences, Technical Writing, Regulatory Affairs, or 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.

Responsibilities

• 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.

Skills

Regulatory knowledge

Project coordination

Documentation quality

Attention to detail

Communication skills

MS Office

Education

Bachelor's degree in Life Sciences, Technical Writing, Regulatory Affairs, Project Management, or related field

Tools

Content management systems

Electronic publishing tools

Document control systems

Job description

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.
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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.