Regulatory Affairs Manager - US Regulatory Lead, Rare Disease

Amgen Inc.; Washington (District of Columbia); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Bonuses & incentives

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. is seeking a Regulatory Affairs Manager – US Regulatory Lead, Rare Disease, to drive regulatory strategies for assigned products in the United States. You will coordinate with federal, state, and local agencies to ensure compliance and timely approvals.

The role involves leading regulatory submissions, interacting with agencies, and contributing to global plans and labeling. Qualifications include advanced degrees with substantial regulatory experience and excellent cross-functional

Qualifications

• Doctorate degree.
• Master’s degree and 2 years of Regulatory Affairs experience.
• Bachelor’s degree and 4 years of Regulatory Affairs experience.
• Associates degree and 8 years of Regulatory Affairs experience.
• High school diploma / GED and 10 years of Regulatory Affairs experience.

Responsibilities

• Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission).
• Act as the point of contact with regulatory agencies.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure and support local regulatory product compliance (eg, agency commitments).
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures.
• Assist the GRL by preparing supportive documentation for regulatory deliverables and managing responses to agency questions.
• Provide primary authorship to routine regulatory correspondence.

Education

Doctorate degree

Master’s degree and 2 years of Regulatory Affairs experience

Bachelor’s degree and 4 years of Regulatory Affairs experience

Associates degree and 8 years of Regulatory Affairs experience

High school diploma / GED and 10 years of Regulatory Affairs experience

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Regulatory Affairs Manager – US Regulatory Lead, Rare Disease

What you will do

Let’s do this. Let’s change the world. The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services.

In this vital role you will be assigned to one or more Amgen products, and plan and execute the Regulatory strategies for that product(s) in their country(ies). Specific responsibilities include but are not limited to:

• Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission).
• Act as the point of contact with regulatory agencies.
• Provide guidance on local mechanisms to optimize product development and regulatory approvals.
• Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
• Ensure and support local regulatory product compliance (eg, agency commitments).
• Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
• Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
• Provide primary authorship to routine regulatory correspondence.

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 leader with these qualifications.

Basic Qualifications

Doctorate degree

OR

Master’s degree and 2 years of Regulatory Affairs experience

OR

Bachelor’s degree and 4 years of Regulatory Affairs experience

OR

Associates degree and 8 years of Regulatory Affairs experience

OR

High school diploma / GED and 10 years of Regulatory Affairs experience

Preferred Qualifications

• Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
• Regulated industry, science or clinical practice experience
• Organizational skills – detail oriented and can deal with frequent changes in product activity

What you can expect from 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 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.

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.

Sponsorship

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. 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.