Regulatory Affairs Submission Writer

Job Responsibilities:

• Create, review, and edit regulatory documents including submission dossiers, technical files, and other compliance-related documents.
• Ensure all documents meet regulatory standards and guidelines.
• Maintain and update documentation to reflect changes in regulations and standards.
• Work closely with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to gather and interpret technical information.
• Collaborate with subject matter experts to ensure accuracy and completeness of documentation.
• Prepare and compile documents for regulatory submissions to various health authorities (FDA, EMA, etc.).
• Ensure timely and accurate submission of regulatory documents.
• Track submission status and manage responses to regulatory authorities.
• Stay current with regulatory requirements and industry standards.
• Implement and maintain best practices for regulatory documentation.
• Conduct audits and reviews of documentation to ensure compliance.
• Provide training and support to team members on regulatory documentation processes and standards.
• Develop and maintain templates and guidelines for regulatory documents.

Qualifications:

• Bachelor’s degree in Life Sciences, Technical Writing, Communications, or a related field.
• Minimum of 1 year of experience in regulatory writing or a related field.
• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ISO).
• Proficiency in technical writing and editing.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to work independently and manage multiple projects simultaneously.
• Proficiency in document management systems and software.