Associate Director, Regulatory Affairs Medical Writing (Biotech)

Location: Remote within the United States with periodic travel to hirify.global' offices in Boston for in-person collaboration and business operations.

Salary: $193,000–$215,000 USD annually, plus potential discretionary annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Author and coordinate high-quality regulatory, nonclinical, clinical, and scientific documents.
• Develop clear scientific messaging for the company's immunology and inflammatory disease pipeline.
• Support regulatory milestones including INDs, amendments, briefing packages, and selected NDA/BLA components.
• Plan, author, review, and deliver documents in partnership with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors.
• Establish and maintain medical writing processes and templates while building internal capabilities and managing external writing resources.
• Provide hands-on execution and operational leadership as programs and submission activity expand.

Requirements

• Experience in regulatory affairs medical writing within clinical-stage biotechnology or pharmaceutical development.
• Ability to develop regulatory, clinical, nonclinical, and scientific documents with a high standard of accuracy and clarity.
• Experience supporting regulatory submissions and milestones such as INDs, amendments, briefing packages, NDA, or BLA components.
• Ability to collaborate with clinical, regulatory, biostatistics, medical affairs, and external vendor stakeholders.
• Availability to work remotely within the United States and travel periodically to company offices is required.

Culture & Benefits

• Remote work arrangement with periodic in-person collaboration.
• Comprehensive benefits tailored to the hiring country or region and applicable local requirements.
• Potential discretionary annual bonus based on individual and company performance.
• Potential long-term incentive award, such as equity.
• Inclusive workplace committed to equal employment opportunity and reasonable accommodation.