Senior Associate Regulatory Affairs - (Open to remote)

Career Category

Regulatory

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.

Senior Associate - Regulatory Affairs

Live

What you will do

Let’s make the world better for patients with serious illness. In this key role you will assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.

• To coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
• To manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
• To assist the Global Regulatory Lead to manage GRT interactions

The responsibilities of the Regulatory Affairs Senior Associate position are:

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through Amgen systems 
• Appropriately archive regulatory documents and agency communications
• Collaborate with CRO’s / partners to support site initiation
• Complete regulatory forms to support agency communications
• Provide regulatory support through cross-functional interactions in work package teams (eg. commercial and evidence generation teams)
• Support the development and execution of GRT goals

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:

• Master’s degree in a biology, life science, health science, or regulatory science with biology curriculum OR
• Bachelor’s degree and 2 years of Regulatory experience or
• Associate’s degree and 6 years of Regulatory experience or
• High school diploma / GED and 8 years of Regulatory experience

Preferred Qualifications:

• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to collaborate with team members to tackle problems and develop a course of action
• Cultural awareness and sensitivity to achieve global results
• Planning and organizing abilities
• Able to prioritize and balance multiple activities
• Ability to deal with ambiguity
• Ability to influence others
• Some of the vast rewards of working here

Thrive

As we work to develop treatments that impact patients, we also work to ensure our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career path
• 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

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. 
• 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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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

89,063.00 USD - 109,121.00 USD