Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.

This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance with global regulations and standards across multiple markets. You will collaborate closely with quality, operations, and regulatory authorities to navigate complex regulatory environments and drive successful product registrations and approvals, operations, and business support.

In this role, you will have the opportunity to:

• Lead regulatory submissions, including pre-market applications, product registrations, post-approval updates, by ensuring accuracy, completeness, and timeliness.
• Monitor and interpret global regulatory requirements and trends, provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities. Remain knowledgeable of emerging regulatory developments, guidelines, and best practices in global markets, and proactively communicate updates and potential impacts to the organization.
• Oversee regulatory submission activities including the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc.
• Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial services. In coordination with Quality Assurance, support and liaise with regulatory officials and or clients during site inspections and audits.
• Provide regulatory expertise and guidance to internal teams, including commercial, R&D, quality, clinical, and marketing, throughout the drug product cycle.
• Responsible for the qualification and management of vendors and maintaining the approved supplier list.
• Lead and manage a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.

The essential requirements of the job include:

• Bachelor's degree in a relevant scientific discipline; at least 12+ years of relevant experience in a QRA position supporting drug product commercialization required, with a minimum of 3 years in a managing a team.
• Experience leading regulatory submissions and interactions with regulatory authorities in different countries with In-depth knowledge of global regulatory requirements, standards, and guidelines, with a focus on key markets.
• Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application.
• Strong leadership and management skills, with a track record of building and developing high-performing teams.
• Excellent analytical, problem-solving, and decision-making abilities; strong written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel 25% to Fargo, ND along with other Aldevron sites, meetings, and/or client locations as business needs require