Senior Specialist, Regulatory Affairs (Biotechnology)

Location: Summit, New Jersey, United States

Annual base pay: $135,000–$150,000, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and infectious-disease treatments that activate and strengthen the immune system.

What you will do

• Serve as a Regulatory Affairs subject matter expert for the department and wider organization.
• Prepare, review, and approve Common Technical Document materials for technical content and regulatory compliance.
• Maintain compliance with United States and international Health Authority regulations for products in development and on the market.
• Assist with developing and evaluating regulatory strategies.
• Monitor changes and trends in the regulatory environment that may affect company products.
• Author and review departmental and cross-functional standard operating procedures and support special projects.

Requirements

• Bachelor’s degree in life sciences with 7+ years of relevant regulatory compliance experience in pharmaceutical drug development, or a master’s degree with 5+ years of relevant experience.
• Experience organizing responses to Regulatory Authority requests.
• Knowledge of FDA, ICH, and other regulatory guidance documents and requirements.
• Strong knowledge of Health Authority regulations, document management, and Microsoft Office.
• Strong organizational, written and oral communication, project management, and attention-to-detail skills.
• Ability to meet firm deadlines, manage conflicting priorities, and adapt to changing requirements.

Nice to have

• Experience with United States and international Health Authority regulatory submissions.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities within a growing, publicly traded biopharmaceutical company.
• Medical, dental, and vision plan options, health and financial wellness programs, and an Employee Assistance Program.
• Life, disability, flexible spending, retirement, education savings, legal, identity protection, pet insurance, discounts, and other benefit options for eligible employees.
• Paid time off includes 11 holidays; exempt employees are eligible for unlimited PTO, while non-exempt employees receive vacation, health pay, personal, and cultural days.