AddressAt 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 the Regulatory Affairs & Compliance department located in Fargo, North Dakota and will be remote with some travel. 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 be a part of the Regulatory Affairs & Compliance team and report to the Director of Regulatory Affairs & Compliance responsible for planning, developing, and executing domestic and international regulatory compliance strategies related to statutory expectations and guidance documentation.
In this role, you will have the opportunity to:
Direct, author, coordinate, compile, and submit U.S. regulatory submissions, including filing and/or creation of Master Files, INDs, BLAs, and other Marketing Authorizations.
Review and approve labeling, marketing, and promotional literature to ensure that regulatory requirements are satisfied.
Provide regulatory guidance (ie, CGMP and CMC compliance requirements and trends) to internal stakeholders (eg, Commercial, R&D, Operations, Supply Chain, Quality Control, and Quality Assurance departments) and external customers regarding design, development, evaluation, and/or marketing of products.
Represent Aldevron before domestic regulatory agencies on major policy matters or decisions regarding company products or processes. This would include responding to inquiries and requests for information.
Interface and proactively build relationships with the FDA. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
The essential requirements of the job include:
8+ years of experience in Quality, Regulatory, Compliance, and/or Validation is required.
Bachelor's degree, or equivalent, is required.
Demonstrated, effective Customer Service and Project Management skills are a must.
Strong writing skills (eg, proficiency with MS Suites tools, research, edit/revise, grammar, and organization) are a must.
Up to 25% travel.
It would be a plus if you also possess previous experience in:
Current Good Manufacturing Practice in advanced therapies.
Advanced degree (eg, MS, PhD, JD, MD) are preferred.
RAC, TOPRA, ASQ, and similar certifications in Regulatory or Quality are preferred.
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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 $110,000 - $140,000. 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.
