Regulatory Affairs Senior Associate

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the 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.

Responsibilities:

• Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug IND applications Biologic License Applications BLAs and New Drug Applications NDAs; advisory committee meeting preparations)
• Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports amendments) in collaboration with USRL
• Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
• Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
• Actively support regulatory compliance and ensure compliance of submissions to the US FDA
• Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables including for example regulatory landscapes or research for the regulatory strategy and/or target product label.
• Coordinate collection of functional documents in support of regulatory applications
• Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg agendas and meeting minutes)
• Assist the USRL in managing the process for responding to FDA questions
• Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Complete regulatory forms to support agency communications (e.g. FDA form 1571)
• 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
• Support the development and execution of GRT goals

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 go-getter with these qualifications.

Basic Qualifications:

Masters degree

Or

Bachelors degree and 2 years ofregulatory or pharmaceutical experience

Or

Associates degree and 6 years of regulatory or pharmaceutical experience

Or

High school diploma / GED and 8 years of regulatory or pharmaceutical experience

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 well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

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.

Sponsorship for this role is not guaranteed.

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