Regulatory Affairs Manager

Key Responsibilities

• Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows.
• Assist in developing standardized templates and structured data formats to ensure consistent and compliant submissions.
• Contribute to projects focused on applying AI and structured content/data management (SCDM) for regulatory use cases.
• Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation initiatives and data standards.
• Monitor industry trends and guidance to maintain up-to-date knowledge of digital and regulatory innovations.
• Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms.
• Participate in training activities to expand internal capabilities in digital tools and regulatory data automation.
• Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards.

Basic Qualifications

• Doctorate degree OR
• Master's degree with 3 years of directly related experience OR
• Bachelor's degree with 5 years of directly related experience
• Experience managing and leading a team in a regulatory or compliance environment

Preferred Qualifications

• Degree in life sciences, digital or data science, biochemistry, or chemistry
• Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements
• Background or experience in digitalization, automation, and software development
• Background in manufacturing, process development, quality control, or quality assurance
• Hands-on experience with Veeva Vault platforms and regulatory technology solutions