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JTI
Washington, DC, United States
Search 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: Washington, DC, US, 00000 We’re JTI, Japan Tobacco International and we beli
Job Source: JTIAmgen
Washington, DC, United States
**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
Job Source: AmgenHR Retail
Bethesda, MD, United States
Regulatory Affairs Manager - (MGRRA_COMPANY_1) Share this job as a link in your status update to LinkedIn. Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multi
Job Source: HR RetailTechnical Resources International
Bethesda, MD, United States
Job Title Regulatory Affairs Manager Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application
Job Source: Technical Resources InternationalTechnical Resources International
Bethesda, MD, United States
Job Title MANAGER, REGULATORY AFFAIRS Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type Full-Time Education Bachelor's Degree Travel None Job Description Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Applicatio
Job Source: Technical Resources InternationalJohns Hopkins Medicine
Bethesda, MD, United States
The Johns Hopkins Health System Corporation is a not-for-profit organization dedicated to providing the highest quality of care in the treatment and prevention of human illness. JHHS is an academically based health system consisting of: The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Johns Hopkins Howard County Medical Center, Sub
Job Source: Johns Hopkins MedicinePhilip Morris USA
Washington, DC, United States
Manager Regulatory Affairs Be a part of a revolutionary change At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. In late 2022, PMI acquired Swedish Match and its leading oral nicotine product portfolio. We can now provide legal a
Job Source: Philip Morris USAJT International S.A.
Washington, DC, United States
We'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 to be present in 130 countries. But our business isn't just busine
Job Source: JT International S.A.Washington D.C.
The purpose of this position is to support the regulatory, safety and product development needs of the Amgen Biosimilars Operating Unit through detailed development and implementation of global regulatory strategies, submissions, and plans.
This position will support:
+ Global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans throughout the product lifecycle.
+ Development of CMC and analytical dossiers required for registration of biosimilar products in support of agency interactions, global clinical trials, and initial marketing applications.
+ Initial management of long term CMC planning and regulatory CMC submissions for licensed products.
Key Activities:
+ Contributes to one or more product development teams; may act as product lead for one or more products.
+ Provides CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies
+ Executes regulatory strategy with respect to preparation of submissions including analytical similairty packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents.
+ Supports cross-functional teams in development and submission of Quality/Operations/CMC regulatory documents, including responses to questions from regulatory authorities
+ Supports CMC-related agency interactions
+ Represents RA CMC at relevant team meetings
+ Complies with Amgen Regulatory CMC processes
+ Identifies and supports changes to process and strategy in response to internal Amgen initiatives and changes in external regulatory policy and guidance
+ Collaborates with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)
**Basic Qualifications**
Doctorate degree
OR
Master’s degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Bachelor’s degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
Associate’s degree and 10 years of regulatory, CMC, manufacturing, testing or process/product development experience
OR
High school diploma / GED and 12 years of regulatory, CMC, manufacturing, testing or process/product development experience
**Preferred Qualifications**
Planning and organizing abilities
Managing multiple activities
Problem solving abilities
Setting priorities
Team work
Multi-disciplinary nature
Dealing with ambiguity
Action oriented
Flexibility with day-to-day requirements
Conflict management
Strong oral and written communication skills
Excellent interpersonal and organizational skills
Ability to provide support for team members
**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**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
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
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.
Email Alert for Regulatory Affairs Manager - Biosimilars_ jobs in Washington D.C.
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