Locations: Position can be located in the following US locations, South San Francisco, Vacaville or Oceanside, CA, or Hillsboro, OR as well as in the following EU locations, Basel or Kaiseraugst, Switzerland, Mannheim or Penzberg, Germany
In the position of Regulatory Program Director in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs. This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products. Demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork, and communication is a requirement for this role.
You will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. You will be responsible for timely compilation of all necessary documentation for regulatory submissions to support technical content of regulatory submissions.
You will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics. With a focus on biologics marketed products, you will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.
Additionally, you will support departmental business processes to document and improve best practices and work efficiencies. The Regulatory Program Director must maintain a high level of professionalism, efficiency, and follow-through as the primary regulatory liaison for the assigned product. The successful candidate will demonstrate effective problem solving, strong understanding of CMC regulatory, excellent interpersonal/collaboration skills and the ability to prioritize multiple tasks.
Must have a proven ability to communicate effectively in both a written and verbal format. Have a demonstrated ability to work both independently or collaboratively in a team structure, including a proven ability to work well under pressure. The incumbent will be skilled to lead communications with FDA and other regulatory agencies to facilitate review and approval of submissions.