Regulatory Affairs Mgr

Additional job responsibilities include:

• Lead submission for annual reports, facility registrations, facility renewals, and product renewals
• Potential to oversee or manage staff
• Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams
• Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions
• Preparing and/or over seeing preparation of 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 and/or Device 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 CMC procedures and systems
• Provide report status of activities and projects to teams and department
• Participate in cross-functional special project teams

Basic Qualifications:

Doctorate degree OR

Master's degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR

Bachelor's degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

• BS degree in Life Science
• Experience managing or hovering staff members
• 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