Additional job responsibilities include:
- Lead submission for annual reports, facility registrations, facility renewals, and product renewals
- Interact with authors/reviewers and subject matter experts with respect to delivery of CMC and/or Device documents required for regulatory submissions
- Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications
- Coordination, preparation, collection and/or legalization of CMC country specific documents
- Document and archive CMC submissions and related communications in the document management system
- Initiate and maintain CMC product and/or Device timelines at the direction of product lead
- Interface with the regulatory operations team
- Train staff on select procedures and systems
- Provide report status of activities and projects to teams and department
- Participate in cross-functional special project teams
Basic Qualifications:
- Master s degree OR
- Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
- Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
- OR
- High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry
Preferred Qualifications:
- BS degree in Life Science
- Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
- Experience in IVD, Device or Combination Product regulatory submission process
- Regulatory CMC specific knowledge and experience
- Mature project management and organizational skills
- Strong and effective oral and written communication skills
- Experience in Veeva Vault platforms
