- 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.
- 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.
- 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.
-
Director, Regulatory Affairs
1 day ago
American Pharmacists Association Washington, United StatesDirector, Regulatory Affairs · Washington, D.C. · The American Pharmacists Association is the largest association representing pharmacists in all practice settings in the United States and is the only organization advancing the entire pharmacy profession. · Our expert staff, a ...
-
State Regulatory Affairs Internship
3 days ago
Edison Electric Institute Washington, United States InternshipSHIPOverview · The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affai ...
-
State Regulatory Affairs Internship
1 day ago
Edison Electric Institute Washington, United States InternshipSHIPOverview · The Edison Electric Institute (EEI) is seeking a talented and committed intern to join the State Regulatory Affairs team this summer. This role provides the opportunity to learn about and support the portfolio of projects and programs within our state regulatory affai ...
-
Principal Regulatory Affairs Specialist
3 days ago
Philips Washington, United StatesPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) · The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organi ...
-
Regulatory Affairs Manager
1 week ago
JTI Inc Washington, United StatesWe're JTI, Japan Tobacco International and we believe in freedom. We think that the possibilities are limitless when you're free to choose. In fact, we've spent the last 20 years innovating, creating new and better products for our consumers to choose from. It's how we've grown t ...
-
Regulatory Affairs Manager
5 days ago
JTI Inc Washington, United StatesSearch by keyword and location and click "create alert" to receive your job alerts by email: · Select how often (in days) to receive an alert: · Professional area: · Corporate Affairs & Communications · Contract type: · Permanent · Professional level: · Experienced · Location: ...
-
Head of Regulatory Affairs
3 weeks ago
Square Washington, United StatesBlock is one company built from many blocks, all united by the same purpose of economic empowerment. The blocks that form our foundational teams People, Finance, Counsel, Hardware, Information Security, Platform Infrastructure Engineering, and more provide support and guidance at ...
-
Head of Regulatory Affairs
3 weeks ago
Square Washington, United StatesBlock is one company built from many blocks, all united by the same purpose of economic empowerment. The blocks that form our foundational teams People, Finance, Counsel, Hardware, Information Security, Platform Infrastructure Engineering, and more provide support and guidance at ...
-
Head of Regulatory Affairs
2 weeks ago
Block USA Washington, United StatesJob DescriptionBlock is looking for an experienced policy and regulatory strategist to serve as our Head of Regulatory Affairs. As a senior level individual contributor, you will develop and execute Blocks strategy for proactive engagement with regulators. You will manage efforts ...
-
Director, Regulatory Affairs, FERC
3 weeks ago
Invenergy Washington, United StatesDirector, Regulatory Affairs, FERC page is loaded · Director, Regulatory Affairs, FERC · Apply · locations · Washington, DC · time type · Full time · posted on · Posted 6 Days Ago · job requisition id · R05798 · Invenergy drives innovation in energy. Powered by decades ...
-
Regulatory Affairs Senior Director
5 days ago
Amgen Washington, United StatesHOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators wh ...
-
A-Gas Washington, United StatesVice President, Regulatory · About A-Gas · A-Gas is the global expert in the supply and full life-cycle management of specialty chemicals and gases, providing refrigerants, blowing agents, fire protection agents, and carbon credits to our customers around the world. With indust ...
-
Aequor Technologies Washington, United States Part timeFully Remote · Part-Time Mon - Fri 9 AM - 1 PM EST · SCOPE OF RESPONSIBILITIES: · accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team · will be at ease working in a matrix environment and be able to navigate ambiguity to drive decisi ...
-
Regulatory Affairs Specialist Project Lead I
2 days ago
Integrated Resources Washington, United StatesJob Title: Regulatory Affairs Specialist Project Lead I · Location: Washington D.C., DC (Fully Remote) · Duration: 06 months + · Part-Time Role- (Mon - Fri 9 AM - 1 PM EST) · Job Description: · Fully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different ...
-
Regulatory Affairs Specialist Project Lead
2 weeks ago
Cynet Systems Washington, United StatesJob Description: · Responsibilities: Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory ...
-
Counsel/Senior Counsel, Regulatory Affairs
3 weeks ago
MFA Washington, United StatesPosition Title: Counsel/Senior Counsel, Regulatory Affairs (position title and compensation is commensurate with experience) · Location: Washington, DC (Hybrid) · Reports to: Executive Vice President and Managing Director, Chief Counsel, Head of Global Regulatory Affairs · Compan ...
-
The Pharmaceutical Care Management Association Washington, United StatesSenior Director or Assistant Vice President, Regulatory Affairs · March 11, 2024 · POSITION SUMMARY · Position · Senior Director or Assistant Vice President, Regulatory Affairs · Organization · Pharmaceutical Care Management Association (PCMA) · Location · Washington, D.C ...
-
Regulatory Affairs Specialist Project Lead
3 weeks ago
Lee Hecht Harrison Nederland B.V. Washington, United StatesFully Remote Part-Time Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) Candidates must be located in the US w/possibility of extension · Compensation: $ $91.00/hr · Must-Have Skills: · • 3-6 years of related experience in a pharma regulatory-related role ...
-
Senior Director/Director of Regulatory Affairs
3 weeks ago
Tempus Washington, United StatesPassionate about precision medicine and advancing the healthcare industry? · Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evi ...
-
A-Gas Americas Washington, United StatesVice President, Regulatory · About A-Gas · A-Gas is the global expert in the supply and full life-cycle management of specialty chemicals and gases, providing refrigerants, blowing agents, fire protection agents, and carbon credits to our customers around the world. With industr ...
Senior Manager, Regulatory Affairs - Washington, United States - Danaher Corporation
Description
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 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:
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
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 to request accommodation.
