Regulatory Affairs Manager - Oncology and Regulatory Promotion

Regulatory

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-drive 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 - Oncology and Regulatory Promotion

Lets do this. Lets change the world. 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
• Ensuring deliverables are consistent with the product label, compliant with US FDA regulations and guidance, and adhere to Amgen SOPs and policies
• Identifying opportunities and challenges that impact US product strategy based upon evolving competition, regulatory environment, and clinical data
• Experienced in evaluating appropriate levels of evidence to make product claims
• Mentor Manager level promotional reviewers

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 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

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.

Amgen does not have an Final date to receive applications 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…