The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company’s products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. Regulatory Affairs, Chemistry, Manufacturing […]
Regulatory Affairs Jobs
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Mammotome, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where […]
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your […]
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging […]
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging […]
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At SCIEX, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where […]
**Job Summary:** n Develop China registration strategy and implement regulatory submissions (China IND/CTN etc.) for products within Amgen’s portfolio in compliance with corporate standards and local regulatory requirements. n Develop HA communication strategy for critical issues, apply for & organize HA meeting and finalize the meeting minutes. n Undertake interactions and negotiations with Regulatory Authorities, […]
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 strategy, risks and issues to […]
**Job Summary:** n Develop China registration strategy and implement regulatory submissions (e.g., China IND/ CTN etc.) for products within Amgen’s portfolio in compliance with corporate standards and local regulatory requirements. n Develop HA communication strategy for critical issues, apply for & organize HA meeting and finalize the meeting minutes. n Undertake interactions and negotiations with […]
**Corporate Title** Regulatory Affairs Assoc. Director **Title (Role)** Head of Japan Regulatory Strategy for Oncology and Rare Disease **Specialty** Regulatory Affairs **Team** Local Regulatory Affairs (Japan) **Function** Global Regulatory Affairs and Strategy (GRAAS), R&D **Group Purpose** Facilitate patient access to Amgen products in Japan through executing on our filing plans; providing strategic regulatory guidance on […]
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