Senior Specialist, Regulatory Pharmacologist-Promotions (Biotech)

Location: Summit, New Jersey, United States; onsite. Monday–Friday during standard business hours, with flexibility subject to manager approval.

Annual base pay: $144,000–$160,000, depending on qualifications, experience, and geographic location. The position is also eligible for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded, commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Review and support approval of U.S. promotional materials for pharmaceutical and biologic products.
• Manage correspondence with FDA promotional review divisions, including complex regulatory questions and advisory-comment submissions.
• Develop compliant regulatory strategies for challenging promotional concepts while minimizing regulatory risk.
• Support U.S. commercial teams with regulatory guidance on marketing strategies, promotional objectives, and tactics.
• Monitor evolving FDA regulations, advisory letters, enforcement letters, and policy issues affecting the pharmaceutical and biologics industry.
• Create and improve SOPs, review processes, templates, and departmental strategic initiatives.

Requirements

• Bachelor’s degree in science, healthcare, or a related field plus 7+ years of relevant industry experience; or a master’s degree plus 5+ years; or a PhD/PharmD plus 3+ years.
• At least 3 years of direct experience as the primary reviewer of advertising and promotional materials.
• Demonstrated knowledge of FDA regulations governing advertising and promotion of prescription products.
• Experience interacting with FDA promotional review divisions OPDP/APLB or developing regulatory strategy for a product filing or launch.
• Strong knowledge of pharmacology, immunology, or oncology, with excellent communication, analytical, organizational, and interpersonal skills.
• Ability to work onsite in Summit, New Jersey, in a standard office environment.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing biotechnology company.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and education savings support.
• Paid time off, holidays, and additional wellness, legal, identity protection, pet insurance, and employee discount benefits.