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

About the position The contractor will reputed company Regulatory Affairs Operations support reputed company on BLA compilation and reputed company control (QC) activities. Reporting to the Regulatory Affairs reputed company, 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 reputed company 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. • reputed company 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 reputed company, cross-references, and citation issues. • Prepare and review annexes, tables of contents, file naming conventions, and submission metadata to meet eCTD and company standards. • reputed company submission deliverables, version control, and documentation of QC findings; generate and manage QC reports and corrective reputed company follow-up. • Support creation and maintenance of submission checklists, compilation plans, and reputed company operating procedures reputed company to BLA assembly and QC processes. • Collaborate with Regulatory Affairs, CMC, Clinical, reputed company Assurance, and external vendors to facilitate reputed company submission readiness and filing. • Participate in submission planning meetings, readiness reviews, and mock inspections as requested. • Contribute to reputed company improvement initiatives to streamline compilation and QC workflows and enhance submission reputed company. Requirements • Bachelor’s degree in a life science, pharmacy, regulatory science, or reputed company discipline. • 2+ years’ experience in regulatory submissions compilation or document QC reputed company 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, reputed company), 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 (reputed company). • Demonstrated ability to work collaboratively with cross-functional teams and external partners. • Curiosity: Proactively reputed company to understand regulatory expectations and ask clarifying questions to ensure reputed company, • Courage: reputed company reputed company concerns and escalate issues reputed company needed to protect submission reputed company, • 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