Labeling Strategist (Biotech)

Location: United States — Remote; approximately 10% travel as needed.

Annual salary: $132,972.30–$179,903.70 USD.

Company

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

What you will do

• Develop and maintain global core labeling documents, including Core Data Sheets, core patient information leaflets, and core instructions for use.
• Lead US labeling deliverables, including prescribing information, patient prescribing information, and medication guides.
• Chair Labeling Working Groups and present to cross-functional Executive Labeling Boards.
• Represent labeling on global regulatory teams and provide strategic guidance on target product labeling and regional regulatory plans.
• Manage medium- to high-complexity labeling programs, deviations, annotations, and responses to health authority queries.
• Contribute to annual reports, DSURs, PBRERs, product quality complaint reviews, and the development of direct reports.

Requirements

• Doctorate degree and 2 years of related experience, or master’s degree and 4 years, bachelor’s degree and 6 years, associate’s degree and 10 years, or high school diploma/GED and 12 years of related experience.
• Extensive regulatory affairs knowledge and familiarity with global labeling regulations, standards, processes, and industry practices.
• Understanding of product development, biology, and pharmacology relevant to the therapeutic area.
• Strong project management, analytical thinking, technical writing, communication, negotiation, leadership, and conflict-resolution skills.
• Experience with regulatory information management systems and proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
• Must be based in the United States for this remote role.

Nice to have

• Degree in life science or medicine.
• Pharmaceutical regulatory affairs or product-labeling experience within a therapeutic area.
• Knowledge of FDA, EMA, and other international labeling regulations.
• Experience managing projects of moderate to high complexity.
• Experience with Veeva- or Documentum-based document management systems.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• 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.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.