At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
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
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At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.
The salary range for this role is $150,000 - $170,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
