Manager, CMC Regulatory Affairs – Biologics

. Lead CMC regulatory strategies for assigned biologic products .

Posted 10/15/2026full-timeRensselaer • New York • United StatesMid-LevelSenior💰 $108,000 - $176,000 per yearWebsite

Key responsibilities & impact

Lead CMC regulatory strategies for assigned biologic products
Support CMC development through early phase, submission, and post-market activities
Assess changes and deviations for regulatory impact and filing requirements
Review regulatory filings for compliance with applicable regulations and guidelines
Support regulatory authority interactions, including meetings and information request responses
Develop Working Instructions, SOPs, and Reviewer’s Guides to improve consistency
Identify regulatory process gaps and recommend efficiency improvements
Translate ambiguity into actionable steps and build alignment across teams
Collaborate with Global Regulatory Affairs and CMC collaborators
Support training activities and address technical or regulatory knowledge gaps

What you’ll need

Bachelor’s degree with 6+ years, or advanced degree with 3+ years, in pharmaceutical, biotechnology, or Health Authority settings
2-4 years of CMC Regulatory Affairs experience with worldwide regulations
Strong understanding of global CMC Regulatory Affairs requirements
Experience delivering CMC sections of marketing authorizations, CTA/INDs, and post-approval submissions
Experience supporting biologic products preferred
Experience engaging with FDA or other regulatory authorities preferred
Strong communication, negotiation, strategic thinking, and problem-solving skills
Ability to build cross-functional partnerships, manage competing priorities, and deliver results in dynamic environments
Ability to support training activities and proactively address technical or regulatory knowledge gaps
Must satisfy applicable right-to-work and background-check requirements

Comp & perks