Senior Associate Regulatory Affairs (Open to remote)
HOW 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 biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Associate Regulatory Affairs (Open to remote)
What you will do
Let’s do this. Let’s change the world. In this key role you will, under the direction of a Regional Regulatory Lead, assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Key responsibilities include:
Assist Regional Regulatory Lead to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
Provide and maintain CTA/MA documentation support (e.g. annual reports, amendments) in collaboration with Regional Regulatory Lead
Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications
Review regional component of the Global Regulatory Plan and provide input to operational deliverables
Ensure compliance with submissions to regulatory agencies
Support RRL in review of promotional materials for commercial activities (ex-US)
Collaborate with CRO’s / partners to support site initiation
Coordinate collection of functional documents in support of regulatory applications
As appropriate participate in GRT to support the implementation of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing packages)
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
Approve drug shipment for Amgen and Investigator Initiated Studies
Complete regulatory forms to support agency communications (E.G. Eudract, FDA form 1571)
Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area 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 teams
Actively support regulatory compliance
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The highly competent professional we seek is a go-getter with these qualifications.
Master’s degree OR
Bachelor’s degree & 2 years of Regulatory experience OR
Associates degree & 6 years of Regulatory experience OR
High school diploma / GED & 8 years of Regulatory experience
Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
Regulated industry, science or clinical practice experience
Strong communication skills- oral and written
Ad hoc meeting support
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.
The annual base salary range for this opportunity in the U.S. is $ 83,292 – $104,433.
In addition to the base salary, 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
Objects in your future are closer than they appear. Join us.
If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancers, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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.
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