Regulatory Affairs Manager

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 submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket 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 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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR
• Masters degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR
• Bachelors degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry

Preferred Qualifications:

• Experience managing or overing staff members
• Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
• 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