Regulatory Affairs Manager - Oncology and Regulatory Promotion

Career Category

Regulatory

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.

What you will do

In this vital role you will be responsible for formulating and communicating the regulatory promotional position for approved and/or pipeline Oncology products and disease state.

Responsibilities

• Provide strategic direction for product and disease communications and associated activities by interpreting current regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public
• Serve as a regulatory advertising and promotion lead for approved and/or pipeline Oncology product and disease state
• Ensure deliverables are consistent with the product label, compliant with US FDA regulations and guidance, and adhere to Amgen SOPs and policies
• Identify opportunities and challenges that impact US product strategy based upon evolving competition, regulatory environment, and clinical data
• Evaluate appropriate levels of evidence to make product claims
• Mentor Manager level promotional reviewers

What we expect of you

Basic Qualifications

• Doctorate degree; OR
• Master’s degree and 2 years of industry experience; OR
• Bachelor’s degree and 4 years of industry experience; OR
• Associate’s degree and 8 years of industry experience; OR
• High school diploma / GED and 10 years of industry experience

Preferred Qualifications

• 2 years experience in Oncology
• Experience in interpretation of government regulations, policies, and guidance
• Strong clinical data analysis skills
• Ability to use judgement and data to formulate and communicate positions on complex issues
• Experience collaborating within large cross-functional teams

What you can expect from us

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $112,744 – $152,536 USD. Actual salary will vary based on several factors including relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, 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
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Application deadline

Amgen does not have an application deadline for this position; applications will be accepted until a sufficient number is received or a candidate is selected.

Sponsorship

Sponsorship for this role is not guaranteed.

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. Reasonable accommodation is available for individuals with disabilities upon request.