Regulatory Affairs Operations - BLA Compilation & QC Support (contractor)

About the position The contractor will provide Regulatory Affairs Operations support focused on BLA compilation and quality control (QC) activities. Reporting to the Regulatory Affairs lead, this role contributes to the preparation, assembly, and QC of regulatory submission components for Biologics License Applications (BLAs) and associated regulatory interactions. The contractor will work closely with cross-functional teams including CMC, clinical, pharmacovigilance, and quality to ensure submission content is complete, accurate, and compliant with regulatory requirements and internal standards. The role emphasizes meticulous document management, rigorous QC practices, and adherence to regulatory timelines. Responsibilities • Support assembly and maintenance of BLA submission modules (including CMC, nonclinical, and clinical sections) ensuring adherence to regulatory guidance and company templates. • Perform detailed QC of submission documents for completeness, formatting, consistency, and compliance with regional and global regulatory requirements (e.g., FDA eCTD specifications). • Coordinate with document owners and subject matter experts to resolve content discrepancies, missing elements, cross-references, and citation issues. • Prepare and review annexes, tables of contents, file naming conventions, and submission metadata to meet eCTD and company standards. • Track submission deliverables, version control, and documentation of QC findings; generate and manage QC reports and corrective action follow-up. • Support creation and maintenance of submission checklists, compilation plans, and standard operating procedures related to BLA assembly and QC processes. • Collaborate with Regulatory Affairs, CMC, Clinical, Quality Assurance, and external vendors to facilitate timely submission readiness and filing. • Participate in submission planning meetings, readiness reviews, and mock inspections as requested. • Contribute to continuous improvement initiatives to streamline compilation and QC workflows and enhance submission quality. Requirements • Bachelor’s degree in a life science, pharmacy, regulatory science, or related discipline. • 2+ years’ experience in regulatory submissions compilation or document QC within pharmaceutical, biotech, or CRO settings; specific BLA or biologics submission experience preferred. • Practical knowledge of eCTD specifications and submission lifecycle processes. • Familiarity with regulatory agency requirements (FDA) and guidance relevant to BLAs and biologics. • Strong attention to detail with demonstrated experience performing document-level and cross-document QC. • Proficient with document management systems, MS Office (Word, Excel), and PDF editing/annotation tools; experience with submission publishing software is a plus. • Excellent organizational skills, with the ability to prioritize tasks and meet tight deadlines in a matrixed environment. • Effective written and verbal communication skills in English (United States). • Demonstrated ability to work collaboratively with cross-functional teams and external partners. • Curiosity: Proactively seek to understand regulatory expectations and ask clarifying questions to ensure quality, • Courage: Raise quality concerns and escalate issues when needed to protect submission integrity, • Collaboration: Build strong working relationships across functions to drive on-time and compliant submissions, • Credibility: Be reliable, transparent, and accountable in documentation and communication. Apply tot his job Apply To this Job