Current jobs related to Regulatory Affairs Senior Manager - Washington DC - Amgen

  • Corporate Affairs Senior Manager

    5 months ago

    Washington D.C., United States Amgen Full time

    HOW 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 Specialist

    4 weeks ago

    Washington, United States Vision Achievement Full time

    Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Vision Achievement. As a Regulatory Affairs Specialist, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure, appropriate to the level of risk in a...

  • Regulatory Affairs Specialist

    1 week ago

    Washington, Washington, D.C., United States Avalere Health Full time

    Regulatory Affairs SpecialistAvalere Health is seeking a highly skilled Regulatory Affairs Specialist to support our work in advisory services. The successful candidate will be responsible for developing and driving the FDA regulatory strategy business through thought leadership and building client relationships.The ideal candidate will possess a...

  • Senior Manager, Lead for Regulatory Policy

    4 days ago

    Washington, Pennsylvania, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a highly skilled Senior Manager, Lead for U.S. Regulatory Policy to develop and implement the organization's regulatory policy strategy.As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S., Europe, and rest of world issues of a regulatory and policy nature impacting the plasma-derived therapies industry.Key...

  • Regulatory Affairs Director

    3 days ago

    Washington, Washington, D.C., United States Exelon Corporation Full time

    Job SummaryExelon Corporation is seeking a highly skilled Regulatory Affairs Director to lead the development and implementation of strategic initiatives that drive business growth and success. The ideal candidate will have a strong background in regulatory affairs, with experience in managing complex regulatory issues and developing effective strategies to...

  • Senior Manager, Federal Government Affairs Lead

    1 week ago

    Washington, Washington, D.C., United States Specialty Equipment Market Association. Full time

    Job Title: Senior Manager, Federal Government AffairsSEMA is seeking a seasoned professional to lead our government relations efforts in Washington, D.C. As Senior Manager, Federal Government Affairs, you will be responsible for analyzing federal legislation and regulations, communicating with members, and advocating for the industry's interests on Capitol...

  • Regulatory Affairs Specialist

    3 days ago

    Washington, Washington, D.C., United States Exelon Corporation Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Exelon Corporation. This role will be responsible for developing and enhancing ComEd's regulatory relationship with the Illinois Commerce Commission, its Staff and Stakeholders.The ideal candidate will have a strong understanding of the Illinois Public Utilities Act and the...

  • Senior Attorney

    3 days ago

    Washington, United States National Association of Broadcasters Full time

    Job SummaryThe National Association of Broadcasters seeks a highly skilled attorney to join its Legal and Regulatory Affairs department. As a key member of the team, you will be responsible for developing and advancing the organization's policy goals with federal agencies, the Executive branch, and federal and state courts.This role involves significant...

  • Senior Manager, Lead for Regulatory Policy

    2 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    Job SummaryPPTA seeks a highly skilled Senior Manager, Lead for U.S. Regulatory Policy to lead the development and implementation of the organization's U.S. regulatory policy strategy.Key ResponsibilitiesDevelop and execute a comprehensive U.S. regulatory policy strategy to advance the interests of the plasma-derived therapies industry.Collaborate with...

  • Senior Manager, Lead for U.S. Regulatory Policy

    1 week ago

    washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Regulatory Affairs Director

    4 days ago

    Washington, DC , USA, United States Exelon Corporation Full time

    Job SummaryExelon Corporation is seeking a highly skilled Regulatory Affairs Director to lead the development and implementation of strategic initiatives that drive business growth and profitability. The successful candidate will have a deep understanding of regulatory policies and procedures, as well as excellent communication and leadership skills.Key...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Senior Manager, Lead for U.S. Regulatory Policy

    3 weeks ago

    Washington, United States Plasma Protein Therapeutics Association (PPTA) Full time

    PPTA seeks a Senior Manager, Lead for U.S. Regulatory Policy to lead PPTA’s U.S. regulatory policy strategy and engage with Federal and State regulators such as the FDA, HHS, state department of health and regulatory and science policy agencies, such as the CDC. As part of the Global Regulatory Policy team, the Senior Manager will collaborate on U.S.,...

  • Regulatory Affairs Director

    2 weeks ago

    Washington, DC , USA, United States Exelon Corporation Full time

    Job Title: Regulatory Affairs DirectorExelon Corporation is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies that drive business growth and profitability.Key Responsibilities:Develop and manage regulatory relationships...

  • Senior Government Affairs Strategist

    4 days ago

    Washington, Washington, D.C., United States Veralto Full time

    THE OPPORTUNITYThe Senior Government Affairs Strategist will lead Veralto's government affairs strategy and operations globally, with overall responsibility for managing legislative, regulatory, political, and reputational risks while promoting growth opportunities.This role presents an opportunity to shape Veralto's policy environment and contribute to its...

  • Global Medical Affairs Asset Lead, Senior Director- Uplizna

    3 months ago

    Washington D.C., United States Amgen Full time

    HOW 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...

  • Federal Regulatory and Legal Affairs Specialist

    3 weeks ago

    Washington, United States Verizon Full time

    Job Title: Federal Regulatory and Legal Affairs CounselVerizon is seeking an experienced and talented lawyer/regulatory professional to join its Federal Regulatory & Legal Affairs group. The group's primary practice areas include federal regulatory and legislative matters and related litigation for all Verizon business units.Responsibilities:Develop and...

  • Senior Manager, Political Affairs

    3 weeks ago

    Washington, Pennsylvania, United States American Academy of Family Physicians Full time

    Senior Manager, Political AffairsAs a key member of the Government Relations team at the American Academy of Family Physicians (AAFP), the Senior Manager, Political Affairs will play a critical role in developing and executing strategies to align AAFP's member priorities with the evolving political environment.This position will require a strong...

  • Senior Officer, Legal Affairs and Deputy Senior Counsel

    2 weeks ago

    Washington, United States The Pew Charitable Trusts Full time

    Senior Officer, Legal Affairs and Deputy Senior CounselThe Pew Charitable Trusts is a leading nonprofit organization dedicated to advancing the public interest by informing and shaping public policy. Our Legal Affairs team plays a critical role in supporting the organization's mission by providing expert legal guidance and advice to our programs and...

Regulatory Affairs Senior Manager

3 months ago

Washington DC, United States Amgen Full time

Amgen 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 clinical and commercial approvals for new products and changes

  • Lead and/or support health agency meetings

  • Lead and/or support global filing activities and associated health agency inquiries

  • Support device design and development activities (e.g. design controls and human factors) and documentation reviews

  • Perform regulatory reportability assessments for changes

  • Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions

  • Develop internal best practices and lead process improvement activities

  • Support device supplier engagement and due diligence activities; review regulatory information in quality and supply agreements with partners and suppliers

  • Support quality compliance activities

  • Support Amgen's combination product external engagement initiatives

Basic Qualifications:

  • Doctorate degree and 2 years ofRegulatory Affairs, CMC, medical devices, and/or combination product related experienceORMaster’s degree and 4 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experienceORBachelor’s degree and 6 years ofRegulatory Affairs, CMC, medical devices, and/or combination product related experienceORAssociate’s degree and 10 years ofRegulatory Affairs, CMC, medical devices, and/or combination product related experienceORHigh school diploma / GED and 12 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience

Preferred Qualifications:

  • Master’s degree and 4 years of Regulatory Affairs, CMC, medical devices, and/or combination product related experience

  • Strong writing, communication, and presentation skills

  • Regulatory experience with a drug-delivery device

  • Some experience with drug Clinical or CMC Regulatory Affairs

  • Basic knowledge of device software, SaMD, and digital health technologies (DHT) regulatory requirements

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

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

careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.