QA Regulatory Manager

Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. The Regulatory Compliance team is a part of RA CMC and...

Responsibilities:Product Development & Parallel Project Deliverables:Establish and oversee QA strategy and execution for our core aviation domain products, ensuring timely and quality releases, while simultaneously managing QA for multiple parallel projects.Establish and enforce QA standards, processes, and metrics to meet delivery targets across all...

*Summary*We are seeking a proactive and experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager to lead and uphold regulatory compliance and product quality across our life sciences and IVD product lines. The ideal candidate will have a strong understanding of ISO 13485, FDA QSR/QMSR, EU IVDR, and CDSCO regulatory frameworks, and experience with...

Sr. Associate Regulatory Affairs Career CategoryRegulatory Job Description Job Description: Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of...

Job Description:Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated...

Career CategoryRegulatoryJob Description Job Description:Amgen is a leading human therapeutics company in the biotechnology industry.  For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine.  As a Fortune 500 company serving millions of patients, Amgen continues to be an...

Regulatory Affairs Manager (CMC) Career CategoryInformation Systems Job Description The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory...

Our CompanyAt Teradata, we believe that people thrive when empowered with better information. That's why we built the most complete cloud analytics and data platform for AI. By delivering harmonized data, trusted AI, and faster innovation, we uplift and empower our customers—and our customers' customers—to make better, more confident decisions. The...

Career CategoryInformation SystemsJob DescriptionThe RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is...