Regulatory Publisher- eCTDXpress/Submission Documents
- Up to US$60 per hour + Medical/401K
- Chestnut Ridge, New York
- Pharma & Biotech
Title: Regulatory Publisher
Location: Rockland County, NY-- Mahwah NJ vicinity
Contract Duration: 6 Months (extendable)
Client Type: Pharmaceutical Corporation
- Support the compilation of regulatory submissions and documentation packages.
- Verify that documentation is complete and meets submission-ready standards.
- Work with Regulatory liaisons in the preparation, publishing and electronic filing of Regulatory submissions such as New Drug Applications (NDA), Investigational New Drug Applications (IND), consumer and professional advertising to meet FDA compliance deadlines
- Independently track, assemble, publish and dispatch NDA/ANDA regulatory submissions, including both major applications and amendments/updates to existing regulatory applications.
- Ensure that all documents are filed and archived properly in accordance with regulatory agency requirements.
- Format documents to ensure they comply with electronic and paper standards (bookmarking, hyperlinking, etc.)
- Prepare Failure Mode Effect Analysis (FMEA) sheets and performed risk assessments.
- Perform Process Development studies, CAPA and Root Cause Analysis.
- Author Validation Master Plan, Process/Cleaning Validation Protocols, Equipment Qualification Protocols and Validation Summary Reports.
- Execute OQ and PQ protocols for publishing system validation
- Oversee system support help desk to ensure user ticket issues are resolved in a timely fashion and comply with the company's Service Level Agreement (SLA).
- Evaluate, validate and implement software for eCTD and SPL. Perform validation and testing for final implementation and upgrades, as needed. Maintain familiarity with current eCTD, ESG, and SPL/PLR requirements, reviewing new guidance and updates as they become available, disseminate new material to the department whenever necessary.
- Self-starter with excellent organizational, planning, and follow-up skills.
- Working knowledge of publishing tools such as eCTDXpress and ISI Toolbox
- Ability to work effectively in a team environment and communicate with team members and customers at all levels of the organization.
- Experience in Adobe Acrobat, document scanning, and electronic document management (Documentum, SharePoint or equivalent).
- Knowledge of MS Office(emphasis on MS Word ), MS Excel, and Adobe Acrobat.
- Experience within Regulatory CMC and/or Labelling (preferred).
Sthree US is acting as an Employment Business in relation to this vacancy.