Regulatory Affairs Consultant - CMC Biologics / Plasma Products

Overview

Supports post-approval regulatory activities for biologics and plasma products, with a focus on CMC strategy, compliance, submissions, and global market expansion.

What you'll do

• Develop strategies and plans for post-approval CMC submissions.
• Assess change controls and quality changes in production and quality control.
• Review manufacturing and quality-control study reports and documentation.
• Coordinate submissions with manufacturing, supply chain, quality, and regulatory teams.
• Write and review variation submissions and responses to health-authority questions.
• Maintain worldwide submission information in regulatory information systems.
• Identify, escalate, and mitigate regulatory risks across global markets.

What you'll need

• 5+ years of regulatory affairs experience in technical, CMC, or quality regulatory roles.
• Bachelor’s degree in Chemistry or a related Life Sciences field.
• Expertise in CMC strategy, post-approval processes, and quality documentation.
• Experience writing CMC sections of registration files or variations.
• Previous biologics regulatory CMC experience.
• Knowledge of global CMC and post-approval requirements.
• Strong communication, organization, problem-solving, and documentation skills.

Nice to have

• Knowledge of plasma product manufacturing processes and regulatory requirements.
• Validation, Quality Assurance, or pharmaceutical production experience.
• Understanding of qualification and validation principles.
• Experience with Veeva Vault or other regulatory information management systems.
• Fluency in English and additional languages.

Details

• Remote role in the United States.