Manager, Regulatory CMC (Contract) - Remote

Overview

The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.

In Short

• Contribute to the preparation, review, and coordination of CMC sections for global regulatory submissions.
• Assist with compiling technical data from Manufacturing, QA, and QC teams.
• Maintain and track regulatory submission timelines and deliverables.
• Support responses to health authority information requests related to CMC topics.
• Review and assess change controls for regulatory impact.
• Maintain awareness of relevant regulatory guidance and ICH guidelines.
• Collaborate effectively with cross-functional partners.
• Assist with developing or revising SOPs and working instructions.
• Participate in the organization of regulatory archives and tracking systems.
• Participate in project team meetings providing CMC regulatory support.

Requirements

• Bachelor’s or master’s degree in a scientific or engineering discipline.
• 3+ years of experience in Regulatory Affairs or related experience.
• Exposure to CMC regulatory filings preferred.
• Experience in cell or gene therapy is a plus.
• Understanding of the drug development process.
• Familiarity with ICH guidelines and US/global regulatory requirements.
• Strong organizational and communication skills.
• Detail-oriented with a focus on quality and accuracy.
• Ability to manage multiple tasks in a dynamic environment.
• Proficiency in Microsoft Office tools.

Benefits

• Opportunity to grow in regulatory affairs.
• Work in an innovative, fast-paced biotechnology environment.