Senior Associate - Regulatory Affairs (US-REMOTE)
Senior Associate - Regulatory Affairs (US-REMOTE)
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$ 109121 - 109121
1 Vacancy
Job Description
Career Category
RegulatoryJob Description
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 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)
Live
What you will do
Lets do this. Lets change the 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 US Regulatory Lead to support US regulatory activities (e.g. IND development and submission meeting preparations)
Provide and maintain IND/BLA documentation support (e.g. annual reports amendments) in collaboration with US Regulatory Lead (and Regional Reg Leads as appropriate)
Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
Review US component of the Global Regulatory Strategy Plan and provide input to operational deliverables
Ensure compliance with submissions to regulatory agencies
Coordinate collection of functional documents in support of regulatory applications
As appropriate facilitate and 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 if needed (cover letters etc.)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Assist USRL and GRL as needed
Complete regulatory forms to support agency communications
Provide regulatory support to Commercial Medical and Clinical departments through cross-functional interactions as needed
Support process improvement initiatives standards development and metrics
Assist in template development and maintenance as needed
Respond to specific requests from and communicate relevant issues to GRT
Assist in development of Regulatory Position with teams
Actively support regulatory compliance
Win
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.
Basic Qualifications:
Masters degree OR
Bachelors degree & 2 years of Regulatory experience OR
Associates degree & 6 years of Regulatory experience OR
High school diploma / GED & 8 years of Regulatory experience
Preferred Qualifications:
Masters degree in a biology life science health science curriculum or regulatory science with biology curriculum
Regulated industry science or clinical practice experience
Timeline management
Strong communication skills- oral and written
Organizational skills
Ad hoc meeting support
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.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.
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.
Application deadline
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.
.Salary Range
89063.00 USD - 109121.00 USDRequired Experience:
Senior IC
Employment Type
Full-Time
