Manager, CMC Regulatory Affairs - Biologics

Responsibilities: 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

Key requirements: Bachelor’s degree with 6+ years or advanced degree with 3+ years in pharmaceutical/biotechnology/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 communication negotiation strategic thinking global CMC Regulatory Affairs requirements CMC filings for marketing authorizations, CTA/INDs, post-approval submissions regulatory authority interactions (FDA or others)