Companion Diagnostic Regulatory Affairs Manager
1 month ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Companion Diagnostic Regulatory Affairs ManagerLive
What you will do
Lets do this. Lets change the world. In this vital role you will support in establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. The lead will also specifically develop and implement regulatory strategies and processes for in vitro diagnostics (IVDs)/companion diagnostics (CDxs).Responsibilities include:
Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making.Developing clinical and commercial regulatory strategies for assigned products to enable successful study designs and timely registration of both therapeutic and diagnostic products by regulatory health authorities.Providing regulatory leadership and input to internal teams involved with IVD/CDx development planning, including Diagnostic Development Teams, and to Joint Project Teams with diagnostic partners.Handling interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks, including regulatory submissions (e.g. PMA, 510(k), IDE).In collaboration with diagnostic partners and internal teams, preparing for and implementing meetings with regulatory agencies.Review and approval of key diagnostic regulatory submissions to CDRH and global health authorities (as agreed with diagnostic partners) and corresponding therapeutic dossiers.Interacting with international regulatory colleagues and diagnostic partners to determine best practices & least burdensome regulatory paths towards development & global registration activities.Assessing impact of relevant drug and IVD/CDX regulations on drug and IVD/CDX development & registration activities, respectively.Regulatory support of due diligence activities of external CDx/IVD companies that Amgen may be considering as partners and other due diligence activities as needed.WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degreeOr Masters degree and 3 years of Health Agency or Med-Device or Regulatory experienceOr Bachelors degree and 5 years of Health Agency or Med-Device or Regulatory experienceOr Associates degree and 10 years of Health Agency or Med-Device or Regulatory experienceOr High school diploma / GED and 12 years of Health Agency or Med-Device or Regulatory experience Preferred Qualifications:MS DegreeDegree in Regulatory Affairs, Life Sciences, or Engineering6 plus years of experience in Regulatory Affairs, including United States and international medical device and/or IVD/CDx regulations8 plus years of experience in medical device and/or IVD/CDx industryThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.-
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Regulatory Affairs Senior Manager
4 weeks ago
Washington, Washington, D.C., United States Amgen Full timeAmgen is searching for a Regulatory Affairs Senior Manager for medical devices and drug-device combination products. The Senior Manager will facilitate device platform and product development, global registrations, and lifecycle management by developing and executing regulatory strategies.Key Responsibilities:Develop global regulatory plans to obtain...
-
Regulatory Affairs Senior Manager
4 weeks ago
Washington, Washington, D.C., United States Amgen Full timeAmgen is searching for a Regulatory Affairs Senior Manager for medical devices and drug-device combination products. The Senior Manager will facilitate device platform and product development, global registrations, and lifecycle management by developing and executing regulatory strategies.Key Responsibilities: Develop global regulatory plans to obtain...
-
Regulatory Affairs Director
3 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW 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 who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Regulatory Affairs Director
2 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Senior Manager of Federal Regulatory Affairs
6 days ago
Washington, Washington, D.C., United States Constellation Energy Full timeCompany OverviewAs the leading producer of clean, carbon-free energy in the nation, Constellation Energy is strategically positioned to tackle the challenges posed by the climate crisis. For over a decade, Constellation has been at the forefront of clean energy production, and we are continuously expanding our capabilities and operations. We are committed to...
-
Washington, Washington, D.C., United States Amgen Full timeHOW 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 who achieve togetherresearching, manufacturing, and delivering ever-better products...
-
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Regulatory Affairs and Quality Assurance Consultant
15 hours ago
Washington, Washington, D.C., United States Vision Achievement Full timeJob OverviewPosition Title: Out of Specification (OOS) / Investigation / Data Integrity ConsultantWork Arrangement: Fully RemoteEligibility: Must be a US Citizen or permanent residentEmployment Type: Independent ContractorSector Focus: Life SciencesRelevant Keywords: #lifesciences, #consultant, #RAQARole SummaryWe are in search of skilled independent...
-
Regulatory Affairs, Senior Associate
1 month ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Regulatory Affairs, Senior Associate
1 month ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Global Regulatory Affairs Director
4 weeks ago
Washington, Washington, D.C., United States GlaxoSmithKline Full timeSite Name: USA - Maryland - Rockville, Durham Blackwell Street, Upper Providence, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore, WalthamPosted Date: Aug 8 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and...
-
Senior Associate Regulatory Affairs
3 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Senior Associate Regulatory Affairs
3 weeks ago
Washington, Washington, D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
Senior Regulatory Affairs Specialist
5 days ago
Washington, Washington, D.C., United States Physicians Committee for Responsible Medicine Full timeJob OverviewPosition Summary: A nonprofit organization focused on enhancing human and animal welfare through ethical scientific practices is seeking a highly qualified professional with a master's or doctoral degree in toxicology, pharmacology, cell biology, or a related discipline. The ideal candidate will possess a minimum of five years of experience in a...
-
Public Affairs Manager
1 month ago
Washington, Washington, D.C., United States tapwage Full timeWe believe in the endless power of people when they come together. But we also believe strongly in our responsibility to minimize harm and keep people safe. In this role, you will be responsible for executing global and domestic Public Affairs marketing campaigns around high-priority topics related to integrity, responsibility, elections, misinformation,...
-
Legislative Affairs Assistant
5 days ago
Washington, Washington, D.C., United States National Association of Colleges and Universities Full timePosition OverviewThe National Association of Independent Colleges and Universities (NAICU) is in search of a Legislative Affairs Assistant.About the RoleThe Legislative Affairs Assistant will report directly to the Vice President of Legislative Affairs.This role is classified as Full-Time Exempt.The standard work schedule for NAICU personnel is seven and...
-
Administrator, Government Affairs
1 month ago
Washington, Washington, D.C., United States Cessna & Associates, LLC Full timeOrganization: Healthcare Distribution Alliance (HDA) Position: Administrator, Government Affairs (Senior Administrative Assistant) Reports To: Executive Vice President, Government Affairs Location: Washington, DC/Hybrid Are you a highly organized office professional with exceptional customer service skills and experience managing calendars and...
-
Senior Regulatory Counsel
6 days ago
Washington, Washington, D.C., United States NextEra Energy Full timeCompany OverviewNextEra Energy Resources stands as the premier generator of renewable energy globally, specializing in wind and solar power, alongside being a leader in battery storage solutions. Our mission is to deliver energy-related products and services that stimulate economic growth, safeguard the environment, support local communities, and assist...
