Senior Director, Regulatory Affairs - Remote

Overview

The Senior Director, Regulatory Affairs is responsible for developing and implementing global regulatory strategies for Apogee’s portfolio of projects, ensuring compliance with applicable global regulations and standards.

In Short

• Serve as global regulatory lead on project teams.
• Ensure global regulatory strategies align with corporate goals.
• Perform critical review of submission documents.
• Understand trends in global government regulatory activities.
• Develop and implement effective global regulatory strategies.
• Serve as primary Health Authority contact for projects.
• Lead preparation of documents for health authority interactions.
• Provide leadership in developing regulatory documents.
• Follow company policies for regulatory record keeping.
• Position requires up to 15% travel.

Requirements

• BS/MS/PhD in regulatory affairs or related scientific discipline.
• Regulatory Affairs Certification (RAC) preferred.
• Minimum of 10 years of regulatory experience in drug development.
• Strong preference for candidates with biologics experience.
• Experience in inflammatory & immunological therapeutic areas preferred.
• Strong project management skills.
• Significant experience interacting with health authorities.
• Knowledgeable of pharmaceutical regulations.
• Strong analytical and communication skills.
• Detail-oriented with a desire to work in a fast-paced environment.

Benefits

• Great culture grounded in C.O.R.E. values.
• Opportunity to work in a fast-paced environment.
• Market competitive compensation and benefits package.
• Flexible PTO.
• Two company-wide shutdowns each year.
• Commitment to professional growth and development.
• Regular team meetings to build relationships.