Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance (Biotech)

Location: United States — Thousand Oaks, California / Washington, D.C.

Company

Amgen is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide strategic direction for product and disease communications and activities.
• Formulate and communicate regulatory promotional positions for approved and pipeline products.
• Evaluate proposed promotional materials and supporting evidence through promotional review committees.
• Assess promotional enforcement activities and changing regulatory requirements for business impact.
• Update the Promotions group on regulatory learnings from courses, congresses, and tradeshows.
• Mentor Senior Associate and Manager-level reviewers and identify changes needed to meet promotional regulations.

Requirements

• Doctorate degree and 2 years of related experience, or a master's degree and 4 years of experience.
• Bachelor's degree and 6 years of related experience, or an associate's degree and 10 years of experience.
• High school diploma or GED and 12 years of related experience.
• Experience applying advertising and promotional regulations in a changing regulatory environment.
• Strong analytical judgment, negotiation, persuasion, collaboration, leadership, and strategic skills.
• Clinical knowledge, coaching and mentoring, project management, organization, and time-management skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time off, work-life balance support, and career development opportunities.
• Flexible work models where applicable; sponsorship is not guaranteed.