Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance

Career Category

Regulatory

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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 Sr Manager, Regulatory Promotion & Material Compliance

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public.

This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.

Key Responsibilities:

Promotional review committee experience in evaluating proposed pieces and supporting evidence

Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen

Update the Promotions group on new learning’s and key takeaways from courses, congresses, and tradeshows

Mentor Senior Associate and Manager level reviewers

Assesses promotional programs against Regulatory requirements

Identifies changes required to meet Promotional Regulation

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 and 2 years of related experience

Or

Master’s degree and 4 years of related experience

Or

Bachelor’s degree and 6 years of related experience

Or

Associate’s degree and 10 years of related experience

Or

High school diploma / GED and 12 years of related experience

Preferred Qualifications:

Serves as an advertising and promotions technical authority within the organization

Experience in reading, understanding, and applying promotional regulations to a constantly changing environment

Experience in an environment which requires extensive daily examples of negotiation, persuasion, collaboration, and analytical judgment

Experience understanding and interpreting data/information and its practical application

Leadership

Strategic focus

Collaboration

Independence

Clinical knowledge/understanding

Analytical judgment

Negotiation/persuasion skills

Coaching and mentoring skills

Project management skills

Problem solving skills

Time management skills

Organization

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

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.

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.

. Salary Range

142,579.00USD -192,901.00 USD