Director, CMC and Device Regulatory Affairs

Apogee Therapeutics(1 month ago)

HybridFull TimeDirector$220,000 - $240,000Regulatory Affairs

About this role

The Director, CMC and Device Regulatory Affairs at Apogee Therapeutics is a strategic regulatory leader focused on drug-device combination products, supporting development from early phases through licensure. The role partners across Technical Operations, Quality, Clinical, and Regulatory teams and contributes to company-wide regulatory strategy. It sits within a fast-paced biotechnology company developing biologics for inflammatory and immunology indications.

View Original Listing

Required Skills

CMC Strategy
Device Regulatory
Regulatory Submissions
Cross-Functional Collaboration
Regulatory Risk
Agency Interactions
Change Assessment
Regulatory Archiving
Process Improvement
Project Management

+3 more

Qualifications

Advanced Degree in Chemistry
Advanced Degree in Pharmaceutical Sciences
Advanced Degree in Biochemistry
10+ Years Industry Experience
6+ Years CMC Regulatory Experience

About Apogee Therapeutics

apogeetherapeutics.com

Apogee Therapeutics is a clinical-stage biotechnology company developing differentiated biologics for immunological and inflammatory diseases. The company focuses on high-unmet-need conditions including atopic dermatitis (AD), chronic obstructive pulmonary disease (COPD), asthma and other I&I disorders. Apogee advances therapeutic candidates through clinical development with the goal of delivering best‑in‑class treatments for patients with inflammatory and immune-mediated diseases.