Essential Job Functions
· Performs critical review of regulatory documents for writing standards, metadata, placement standards, logic, content, presentation and clarity to ensure alignment with guidance requirements and regulatory strategy.
· Prepares master table of contents for assigned regulatory documents to define necessary supporting materials. Assists in the coordination and planning of submissions including developing timelines for documentation needs. Communicates approved plans and timelines as appropriate.
· Assists in the writing, editing and formatting of drafts and related materials for all sections of regulatory applications and other drug and product applications. Identifies appropriate source documents. Maintains records to ensure consistent writing methodology over the lifecycle of various applications.
· Interacts with team to provide scientific review and evaluation of regulatory documents to ensure documents meet requirements and are scientifically accurate.
· Develops flowcharts and tables for manufacturing processes for inclusion in regulatory submissions.
· Maintains updated knowledge and familiarity with regulations and standards for compliance purposes.
· Bachelor's degree or equivalent combination of education and experience
· Bachelor's degree in life sciences or related field preferred
· Three or more years experience in one or more of the following areas: biotechnology, regulatory, Chemistry, Manufacturing, and Controls (CMC), clinical, or non-clinical
· Experience in the biopharmaceutical industry writing and/or reviewing regulatory documentation
· Experience in regulatory writing and editing
· Experience in generating and reviewing submission documents for drug applications, amendments, safety reports and technical information packages for government agencies
· Regulatory Affairs Certification (RAC) preferred
· Knowledge of regulatory requirements for licensing biopharmaceuticals
· Knowledge of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), electronic Common Technical Documents (eCTD), and international submission requirements and regulations
· Good verbal and written communications skills
· Good editing and organization skills
· Personal computer and business solutions software skills
· Ability to multi-task between projects
· Ability to work well independently and as part of a team
· Office environment