Regulatory Affairs Manager (Oncology)

Location: United States — Remote

Salary: $112,744–$152,536 annually

Company

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

What you will do

• Formulate and communicate regulatory promotional positions for approved and pipeline oncology products and disease states.
• Provide strategic direction for product and disease communications and related activities.
• Lead regulatory advertising and promotion reviews for oncology products and disease states.
• Ensure deliverables align with product labeling, US FDA regulations and guidance, and internal SOPs and policies.
• Identify opportunities and challenges affecting US product strategy based on competition, regulatory developments, and clinical data.
• Evaluate evidence supporting product claims and 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; or equivalent experience based on the stated education pathways.
• 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 within large cross-functional teams.

Nice to have

• Two years of oncology experience.

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 and career development opportunities.

Hiring process

• Applications are accepted until a candidate is selected or a sufficient number of applications is received.
• Sponsorship is not guaranteed.