Senior Associate Regulatory Affairs (Open to remote)

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION

Youve earned your degree. How will you use that achievement to reach your goals Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Senior Associate - Regulatory Affairs

Live

What you will do

Lets make the world better for patients with serious 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 CROs / 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:

• Masters degree in a biology life science health science or regulatory science with biology curriculum OR

• Bachelors degree and 2 years of Regulatory experience or

• Associates 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

Thrive

Some of the vast rewards of working here

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 Plancomprising health finance and wealth work/life balance and career benefitswith 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.

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.

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