Senior Associate Regulatory Affairs (Biotech)

Location: United States - Remote

Salary: $83,974.90–$113,613.10 annually

Company

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

What you will do

• Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead.
• Prepare, deliver, archive, and maintain documentation for IND, CTA, marketing authorization, amendments, and periodic reports.
• Support US Regulatory Leads and the Global Regulatory Team with regulatory activities, agency meetings, and regulatory strategy execution.
• Create and maintain product regulatory information, history documents, templates, forms, and agency communications.
• Coordinate quality control of regulatory documentation and author routine correspondence, including annual reports and investigator packages.
• Collaborate with CROs and partners to support site initiation and maintain regulatory compliance.

Requirements

• Master’s degree; or bachelor’s degree with 2 years of Regulatory Affairs experience; or associate’s degree with 6 years of experience; or high school diploma/GED with 8 years of experience.
• Strong oral and written communication skills.
• Ability to understand and communicate scientific and clinical information.
• Ability to collaborate, prioritize multiple activities, plan work, and develop practical courses of action.
• Ability to work with ambiguity, influence others, and demonstrate cultural awareness and sensitivity.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Medical, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Paid time-off programs and career development opportunities.

Hiring process

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