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. Come do your best work alongside other innovative, driven professionals in this meaningful role.
**Senior Associate – Regulatory Affairs**
**Live**
**What you will do**
Let’s do this. Let’s change the world. In this vital 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
**Key responsibilities include:**
+ 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
+ Participate in GRT to support execution of regulatory strategy
+ Coordinate QC of regulatory documentation (e.g. briefing materials)
+ Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
+ Assist in template development and maintenance
+ Respond to specific requests from and communicate relevant issues to GRT
+ 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 dynamic professional we seek is a self-starter with these qualifications.
**Basic Qualifications:**
Master’s degree
Or
Bachelor’s degree and 2 years of Regulatory Affairs experience
**Or**
Associate’s degree and 6 years of Regulatory Affairs experience
**Or**
High school diploma / GED and 8 years of Regulatory Affairs 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
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
+ A 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
+ Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
**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.
