Regulatory Site Officer (Pharmaceuticals)

Location: Hybrid position based in Swiftwater, Pennsylvania, USA; US and Puerto Rico residents only

Salary: $90,000–$130,000 per year

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines and vaccines through science, digital, data, and AI-driven innovation.

What you will do

• Manage change control assessments and related regulatory activities for the Swiftwater site.
• Author variations, impacted CTD sections, renewals, and other regulatory submissions for site product registrations.
• Maintain and update regulatory files, CMC documentation, and databases.
• Assess the regulatory impact of changes to site products and services.
• Ensure product compliance with registrations, laws, regulations, standards, and guidelines in applicable markets.
• Support internal and external audits, including regulatory inspections.

Requirements

• Bachelor’s degree.
• At least 3 years of experience in regulatory affairs, change control, or technical writing, or 10 years of experience in GxP-regulated fields.
• Experience preparing regulatory CMC dossiers.
• Strong verbal and written communication skills.
• In-depth understanding of pharmaceutical regulatory requirements and guidelines.
• Ability to analyze complex regulatory documents and data, manage multiple projects, and work independently with high accuracy.

Nice to have

• Experience working with a health authority.

Culture & Benefits

• Supportive, future-focused environment centered on science and innovation.
• Career growth opportunities through promotion or lateral moves.
• Employee rewards and benefits package.
• Healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Work focused on vaccine delivery, resilient supply, and AI-driven innovation.