The Manager Regulatory Publishing will oversee the formatting and publication of electronic documents and regulatory submission results, such as INDs, CTAs, BLAs, MAAs & JNDAs, including their amendments and supplements. The role requires adherence to applicable Regulatory Agency regulations, guidelines, and specifications.
Key Responsibilities:
- Liaise with staff and/or vendors to electronically format, publish documents, and build regulatory submission results, ensuring quality, accuracy, and submission-readiness in accordance with Regulatory agency specifications and internal procedures.
- Mentor multidisciplinary teams on developing submission structure strategies in line with applicable Regulatory Agency regulations, guidelines, and specifications.
- Provide guidance on good documentation and submission practices.
- Assist in developing and maintaining regulatory document processing and submission publishing standards and procedures.
- Coordinate submission activities, including crafting and handling submission table of contents (TOCs) and supervising submission results.
- Ensure consistency and standardization of regulatory submissions across programs.
- Provide mentorship to Reg Submission Management team members and cross-functional groups to resolve issues related to submission schedules, documents readiness, or other submission or regulatory-related requirements.
Requirements:
- Bachelor's Degree or equivalent experience.
- 8+ years of pharmaceutical experience.
- Sophisticated knowledge of Microsoft Word, Adobe Acrobat, and electronic document management systems.
- Knowledge of applicable Regulatory Agency regulations, guidelines, and specifications (e.g., FDA, EMA, PMDA, ICH).
Estimated Salary: $120,000 - $180,000 per year
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