Senior Associate Regulatory Affairs
Senior Associate Regulatory Affairs
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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
Live
What you will do
Lets do this. Lets change the world. In this vital role you will 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.
- Assist U.S. Regulatory Lead to support regional regulatory activities
- Provide and maintain IND/BLA documentation support (e.g. annual reports amendments) in collaboration with U.S. Regulatory Lead
- Create and maintain product regulatory history documents 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 U.S. Regulatory Lead in review of HA interaction activities
- Collaborate with CROs / partners to support site initiation as applicable
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support 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 crossreference letters to support investigator initiated studies
- Approve drug shipment for Amgen and Investigator Initiated Studies
- Complete regulatory forms to support agency communications
- Provide regulatory support to Commercial Medical and Clinical departments through crossfunctional 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
- Support the development and of GRT goals
Win
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a partner 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
- Agendas minutes
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 wellbeing.
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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide 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
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
