We have other current jobs related to this field that you can find below
-
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, 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...
-
Washington, United States Cynet Systems Full timeJob Overview:As a Senior Specialist in Regulatory Affairs Management at Cynet Systems, you will play a pivotal role in navigating the complex landscape of regulatory compliance. Your expertise will be essential in ensuring that our products meet the necessary standards and regulations.Key Responsibilities:Deliver timely and relevant regulatory insights to...
-
Regulatory Affairs Manager in Plastics
23 hours ago
Washington, United States Spelman College Full timeManager of Regulatory Affairs in PlasticsOrganization: Spelman CollegePosition: Manager of Regulatory AffairsReports To: Senior Director of Regulatory AffairsLocation: HybridAre you a skilled communicator with a proactive mindset and a background in regulatory policy looking for a role that fosters professional development? The Spelman College is in search...
-
Regulatory Affairs Manager in Plastics
6 days ago
Washington, United States Spelman College Full timeManager of Regulatory Affairs in PlasticsOrganization: Spelman CollegePosition: Manager of Regulatory AffairsReports To: Senior Director of Regulatory AffairsLocation: Remote/HybridAre you a skilled communicator with a proactive mindset and a background in regulatory policy looking for a role that fosters professional development? The Spelman College is...
-
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...
-
Regulatory Affairs Manager in Plastics
23 hours ago
Washington, United States Spelman College Full timeManager of Compliance for PlasticsOrganization: Spelman CollegePosition: Manager of Regulatory AffairsReports To: Senior Director of Regulatory AffairsLocation: HybridAre you a skilled communicator with a proactive mindset and a background in regulatory policy looking for a role that fosters professional development? The Spelman College is seeking a Manager...
-
Associate, EU Government Relations
4 weeks ago
Washington, United States McLarty Associates Full timeMcLarty Associates (Europe Office/Brussels)Associate, EU Affairs & Public Policy Do you have a background in EU Affairs and Policy Making and bring at least two years of relevant experience? Want to be part of a highly dynamic and experienced global team working across the Atlantic? If you are driven by the passion to deliver tailor-made solutions that help...
-
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...
-
Regulatory Affairs Associate
6 days ago
Washington, United States Jameson Legal Full timePosition Overview:This role presents a unique opportunity for a Regulatory Affairs Associate specializing in FDA and Healthcare law. The successful candidate will provide guidance to clients navigating the complexities of the US Food and Drug Administration's (FDA) regulations within the life sciences sector, which encompasses digital health, medical...
-
Regulatory Affairs Manager in Plastics
16 hours ago
Washington, United States Spelman College Full timeManager of Compliance and Regulatory AffairsOrganization: Spelman CollegePosition: Manager of Compliance and Regulatory AffairsReports To: Senior Director of Regulatory AffairsLocation: Remote/HybridAre you a skilled communicator with a proactive mindset and a background in regulatory frameworks looking for a role that provides professional advancement? The...
-
Regulatory Affairs Senior Manager
4 weeks ago
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 Manager in Plastics
6 days ago
Washington, United States Spelman College Full timeManager of Regulatory Affairs in PlasticsOrganization: Spelman CollegePosition: Manager of Regulatory AffairsReports To: Senior Director of Regulatory AffairsLocation: HybridAre you a skilled communicator with a proactive mindset and a background in regulatory policy looking for a role that promotes professional development? The Spelman College is seeking a...
-
Senior Director, Quality, Technical
4 weeks ago
Washington, United States Consumer Healthcare Products Association Full timeOrganization OverviewFounded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers in the consumer healthcare industry with its core capabilities, including scientific and regulatory affairs, government affairs, and communications. CHPA is the leading voice fighting...
-
Senior Director, Quality, Technical
2 months ago
Washington, United States Consumer Healthcare Products Association Full timeOrganization OverviewFounded in 1881, the Consumer Healthcare Products Association (CHPA) is the national trade association representing the leading manufacturers and marketers in the consumer healthcare industry with its core capabilities, including scientific and regulatory affairs, government affairs, and communications. CHPA is the leading voice fighting...
-
Senior Associate Regulatory Affairs
3 weeks ago
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...
-
Senior Associate US Regulatory Affairs
2 weeks ago
Washington D.C., United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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...
-
Senior Litigation Counsel for Regulatory Affairs
3 hours ago
Washington, DC, USA, United States Federal Election Commission Full timeSenior Litigation Counsel for Regulatory AffairsThe Federal Election Commission seeks a highly skilled and dedicated individual to serve as Senior Litigation Counsel for Regulatory Affairs in the Office of General Counsel.Key Responsibilities:Lead and oversee the division representing the FEC in the U.S. District Courts and the U.S. Courts of Appeals.Develop...
Senior Associate Regulatory Affairs
2 months ago
**HOW MIGHT YOU DEFY IMAGINATION?**
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.
Senior Associate Regulatory Affairs
**Live**
**What you will do**
Lets do this. Lets change the world. In this vital role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
+ To coordinate and execution of US regulatory submissions with the US Regulatory Lead in compliance with corporate standards and local regulatory requirements.
+ To manage and execute of the preparation, delivery and electronic archiving of documentation for inclusion in US regulatory submissions
+ To assist the Global Regulatory Lead to manage GRT interactions
The responsibilities of the Regulatory Affairs Senior Associate position are:
+ Assist US Regulatory Lead to support regional regulatory activities (e.g. IND submissions and agency meetings)
+ Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with Regional Regulatory Lead
+ Create and maintain product regulatory history documents through Amgen systems and appropriately archive all regulatory documents and agency communications
+ Review regional component of the Global Regulatory Plan and provide input to operational deliverables
+ Collaborate with CROs / partners to support site initiation
+ Coordinate collection of functional documents in support of regulatory filings
+ Participate in GRT to support execution of regulatory strategy
+ Coordinate QC of regulatory documentation (e.g. briefing materials)
+ Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
+ Prepare regulatory packages and cross-reference letters to support investigator initiated studies
+ Complete regulatory forms to support agency communications
+ Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
+ Support process improvement initiatives, standards development, and metrics
+ Assist in template development and maintenance
+ Respond to specific requests from and communicate relevant issues to GRT
+ Develop Regulatory Position with GRT
+ Actively support regulatory compliance
+ Support the development and execution of GRT goals
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.
**Basic Qualifications:**
+ Masters degree ORBachelors degree and 2 years of regulatory experience ORAssociates degree and 6 years of regulatory experience ORHigh school diploma / GED and 8 years of regulatory experience
**Preferred Skills:**
+ Master's degree
+ Strong communication skills - both oral and written
+ Ability to understand and communicate scientific/clinical information
+ Ability to resolve conflicts and develop a course of action
+ Cultural awareness and sensitivity to achieve global results
+ Planning and organizing abilities
+ Able to prioritize and manage multiple activities
+ Ability to deal with ambiguity
+ Organizational savvy
+ Negotiation skills
**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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
**Apply now**
**for 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
**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.
