Senior Associate - Regulatory Affairs

Location: United States - Remote

Annual salary: USD 83,974.90–113,613.10

Company

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

What you will do

• Support regional regulatory activities and assist Global or Regional Regulatory Leads.
• Prepare and maintain IND/MA documentation, regulatory packages, annual reports, amendments, and investigator-initiated study materials.
• Create and maintain product regulatory histories in RIM and archive regulatory documents and agency communications.
• Research regulations and contribute to global regulatory strategic plans, regulatory landscapes, and target product labeling.
• Coordinate functional documentation, submission quality control, regulatory correspondence, forms, and responses to agency questions.
• Support regulatory process improvements, standards, templates, metrics, and Regulatory Governance Team activities.

Requirements

• Master’s degree; or a bachelor’s degree and 2 years of Regulatory Affairs experience; or an associate’s degree and 6 years of experience; or a high school diploma/GED and 8 years of experience.
• Experience in Regulatory Affairs and supporting regulatory submissions.
• Ability to prepare regulatory documentation and coordinate cross-functional contributions.
• Must be based in the United States for this remote role.

Nice to have

• Bachelor’s degree in Life Sciences.
• 2–3 years of Regulatory Affairs experience.
• Experience setting up regulatory submissions.

Culture & Benefits

• Collaborative, innovative, and science-based working environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus program and stock-based long-term incentives.
• Paid time off and career development opportunities.

Hiring process

• Applications are accepted until a suitable candidate is selected; no fixed deadline is specified.
• Sponsorship is not guaranteed.