We are seeking a Senior Director, Regulatory CMC to provide leadership in regulatory strategy and submissions as we transition from clinical to commercial stages. Reporting to the VP of Regulatory, this role will drive CMC-focused agency interactions, submission writing, and global regulatory guidance for drug development and lifecycle management.
Key Responsibilities:
Represent Regulatory CMC in cross-functional teams and partnerships with CDMOs and consultants.
Lead global CMC regulatory strategy, ensuring compliance with evolving regulations.
Oversee preparation and submission of CMC content for INDs, CTAs, BLAs, and MAAs.
Manage regulatory CMC submissions and agency interactions, including inspections.
Support manufacturing and analytical development teams in regulatory compliance.
Identify regulatory risks and develop mitigation strategies.
Qualifications:
Advanced degree (Ph.D., Pharm.D., M.S.) in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
12+ years of CMC Regulatory Affairs experience in biologics, including global filings.
Strong knowledge of cGMP, FDA, EMA, and ICH regulations.
Proven ability to manage multiple projects in a fast-paced environment.
Excellent communication and leadership skills.
Ability to travel (~15%). Remote or in-office flexibility available.