Manager, Regulatory CMC - Remote

Overview

The Manager, Regulatory CMC will be responsible for authoring and preparing regulatory packages in support of the chemistry, manufacturing, and controls (CMC) development for our early- to late-stage development pipeline products at Orca Bio, a biotechnology company focused on redefining the transplant process with next-generation cell therapies.

In Short

• Lead the authoring and preparation of regulatory CMC meeting packages.
• Develop and review content for regulatory filings and information requests.
• Support the development of CMC regulatory strategies.
• Work with cross-functional teams to align regulatory packages with development objectives.
• Identify and communicate regulatory risks.
• Monitor regulatory agency activities related to CMC development.
• Assist in evaluating proposed manufacturing changes.
• Participate as a CMC Regulatory representative on project teams.
• Ensure compliance with current regulatory requirements and guidance.

Requirements

• Bachelor’s degree in life sciences; advanced degree preferred.
• 5+ years of experience in the biotech/pharmaceutical industry.
• 4+ years of experience in CMC regulatory affairs.
• Knowledge of cGMP and CMC regulatory requirements.
• Strong scientific writing skills.
• Ability to work effectively in cross-functional teams.
• Initiative-taking and able to manage multiple tasks independently.
• Proficient in MS Project, Office suite, Smartsheet, etc.

Benefits

• Opportunity to work in a cutting-edge biotechnology company.
• Impactful role in improving patient outcomes.
• Collaborative work environment.
• Professional development opportunities.