Regulatory Associate Project Manager (Pharma)

TL;DR

Regulatory Associate Project Manager (Pharma): Managing regulatory submission dossiers and applications for biotech, medtech, and specialty pharmaceutical products with an accent on project planning, cross-functional coordination, and regulatory compliance. Focus on identifying submission risks, analyzing critical paths, and delivering complex global and regional programs to regulatory health authorities.

Location: United States of America; preference for candidates located in California. Travel up to 20%.

Salary: Annualized minimum base pay of $71,000 USD, with comprehensive benefits that may include health insurance, retirement plans, and paid time off.

Company

hirify.global provides consulting and clinical development services for biotech, medtech, specialty pharmaceutical, and diagnostics companies.

What you will do

• Coordinate cross-functional contributions for regulatory submissions.
• Manage preparation and delivery of dossiers and applications to global regulatory authorities.
• Create submission timelines and project plans, including dependency and critical path analysis.
• Identify and mitigate project risks while revising operational strategies to meet deadlines.
• Track billable hours, milestones, project completion, and close-out with the finance team.
• Maintain awareness of regulatory environments, guidelines, and the global competitive landscape.

Requirements

• Bachelor’s degree or international equivalent in a science- or health-related field.
• At least 2 years of experience in the pharmaceutical, medical device, diagnostics, or biotechnology industry.
• 1–2 years of regulatory or project management experience in a CRO, pharmaceutical, device, diagnostics, or biotechnology company.
• Knowledge of the drug development process and experience supporting IND/CTA and marketing application submissions, including 505(b)(1) and 505(b)(2) applications.
• Strong organizational, writing, communication, and time management skills for managing multiple projects.
• Strong understanding of project management software; travel up to 20% is required.

Nice to have

• Background in SmartSheet.
• Location in California.

Culture & Benefits

• Flexible work environment supporting work-life balance.
• Opportunities for professional growth, skills development, and career advancement.
• Comprehensive benefits package that may include health insurance, retirement plans, and paid time off.
• Equal opportunity employment compliant with federal guidelines.