Regulatory Affairs Manager - Oncology and Regulatory Promotion

Location: Washington, D.C., United States

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Provide strategic direction for product and disease communications.
• Lead regulatory advertising and promotion activities for approved and pipeline oncology products.
• Ensure deliverables align with product labeling, US FDA regulations and guidance, and company policies.
• Identify opportunities and challenges affecting US product strategy through analysis of competition, regulatory developments, and clinical data.
• Evaluate the evidence needed to support product claims.
• Mentor manager-level promotional reviewers.

Requirements

• Doctorate degree, or a master's degree with 2 years of industry experience, or a bachelor's degree with 4 years of industry experience, or an associate degree with 8 years of industry experience, or a high school diploma/GED with 10 years of industry experience.
• At least 2 years of oncology experience.
• Experience interpreting government regulations, policies, and guidance.
• Strong clinical data analysis skills.
• Ability to use judgment and data to formulate and communicate positions on complex issues.
• Experience collaborating across large cross-functional teams.

Culture & Benefits

• Retirement and savings plan with company contributions.
• Medical, dental, vision, life, disability, and flexible spending benefits.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.