Associate Director, Regulatory Affairs

The role

The Associate Director, Regulatory Affairs will contribute to the development and implementation of consolidated regulatory strategies. This person will support regulatory planning, execution, and agency interactions to secure and maintain regulatory approvals.

What you will do

• Contribute to the definition of global regulatory strategies.
• Support end-to-end regulatory planning for submissions including INDs, NDAs/BLAs, briefing packages, and orphan drug applications.
• Support oversight of regulatory consultants and vendors.
• Serve as a regulatory liaison for FDA and other global health authorities.
• Prepare materials and support company participation in agency meetings.
• Communicate regulatory risks, timelines, and updates to senior leadership and core project teams.
• Represent Regulatory Affairs on Project Teams, Clinical Teams, and Study Teams.
• Support the identification, selection, and oversight of vendors.
• Ensure global regulatory strategies are compliant with applicable regulations and guidances.
• Develop and maintain regulatory SOPs and best practices.

Required qualifications

• Bachelor’s degree in a scientific discipline or equivalent work experience
• 7+ years of experience in the pharmaceutical/biotech industry
• At least 4 years in Regulatory Affairs roles
• Experience in oncology and across multiple development phases
• Demonstrated experience preparing and supporting global regulatory submissions, particularly NDA/BLA filings with the FDA
• Solid working knowledge of the drug development process and global regulatory pathways
• Good understanding of global regulatory guidelines and their practical application
• Excellent interpersonal, collaboration, and leadership skills
• Highly organized with outstanding communication and project management skills
• Proactive, analytical, and detail-oriented problem solver
• Demonstrated ability to utilize AI tools for day-to-day work

Nice to have

• Advanced degree (MS, PhD, PharmD)
• Global regulatory experience
• Advanced or innovative use of AI

Benefits

• Annual target bonus
• Equity
• Comprehensive suite of competitive benefits

About the company

Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating medicines for patients with serious diseases by unlocking biologically important targets. The company has pioneered a new class of alpha-helical peptides called Helicons™.