Regulatory Affairs Manager
7 hours ago
Job Summary:
Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance.
Join us in revolutionizing regulatory submissions through cutting-edge data automation
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 for consistent and compliant submissions.
- Contribute to projects focused on the application of 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 and data standards.
- Monitor industry trends and guidance to maintain up-to-date knowledge on 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
Masters degree and 3 years of directly related experience OR
Bachelors degree and 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 basic experience in digitalization, automation, software development
Background in manufacturing, process development, quality control, or quality assurance
Hands-on experience with Veeva Vault platforms and regulatory technology solutions.
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