Promotional Regulatory Affairs Submissions Associate (Healthcare)

TL;DR

Promotional Regulatory Affairs Submissions Associate (Healthcare): Coordinating and submitting FDA Form 2253 electronic submissions for promotional materials with an accent on regulatory compliance and quality control. Focus on managing end-to-end submission packages, auditing promotional assets for FDA requirements, and optimizing submission workflows.

Location: Must be based in the United States

Salary: $65,000 - $75,000

Company

hirify.global is a technology-led healthcare solutions provider enabling healthcare organizations to be future-ready through a convergence of healthcare and technology.

What you will do

• Manage the creation, quality check, and submission of electronic FDA Form 2253 packages to OPDP and APLB via the FDA Electronic Submissions Gateway.
• Review promotional assets to verify that all FDA submission requirements, including metadata and asset categorization, are met.
• Collaborate with commercial brand teams to prioritize and sequence compliance copy processing aligned to brand timelines.
• Execute and deliver submission status reports, dashboards, and compliance metrics.
• Maintain regulatory documents and expertise within client content and regulatory systems.
• Identify process bottlenecks and share best practices to improve submission efficiency.

Requirements

• Bachelor’s or Master’s degree in Life sciences or English.
• 2–4 years of experience in the pharmaceutical or healthcare industry.
• Working knowledge of IT systems and document management, specifically Veeva PromoMats.
• Understanding of FDA promotional material regulations and submission processes.
• Must be based in the United States (as per geographic pay area specifications).
• Excellent written and verbal communication skills for cross-functional collaboration.

Nice to have

• Degree in regulatory affairs or a related field.
• Direct experience with FDA 2253 submissions or promotional regulatory affairs.
• Knowledge of Veeva RIM or other enterprise regulatory vaults (ERVs).
• Familiarity with OPDP/APLB submission requirements and the electronic gateway.
• Project management experience and problem-solving aptitude.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) retirement plan.
• Life and disability insurance.
• Paid time off, including vacation and seven sick leave days.
• Paid holidays in accordance with company plans.