Regulatory Affairs Manager - Oncology and Regulatory Promotion

Amgen • Thousand Oaks, CA

1d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager