Job Information
Amgen Regulatory CMC Manager in Washington D.C., District Of Columbia
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Live
What you will do
Facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle
Job Summary
The RA CMC Product Lead is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Product Lead is member of the product team, the Global Operations Team, Global Regulatory Team and is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and coordination with the site and regional CMC representatives on the CMC GRT to develop and execute global regulatory activities.
Key Activities
Contributes to product teams and acts as product lead for one or more commercial products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions; complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance; reports needs for process changes to CMC systems and contributes to process improvements; incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams; reports issues to RA CMC product team management.
Key Responsibilities Include:
Generate and execute of global and country-specific regulatory strategies
Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments
Develop global dossiers for CMC content for post-approval variation an existing CTAs for marketed products
Develop post-approval submissions including maintenance of commercial and clinical applications globally
Support change management activities
Develop response strategy and respond to health authority questions
Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans
Liaise with local regulatory teams to align on filing strategy
Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system
Follow established department regulatory processes to ensure cross-product alignment
Participate as an active member of cross-fucntional teams including Global Regulatory, Operations and Quality as needed
Knowledge and Skills
CMC- specific regulatory knowledge & experience
Basic Qualifications
Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience
OR
Associate’s degree and10 years of directly related experience
OR
High school diploma / GED and12 years of directly related experience
Preferred Qualifications
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
Thrive
What 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 plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
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
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.