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

Preferred Qualifications

Skills Required

Automation