Regulatory Affairs Jobs

Senior Associate Regulatory Affairs

The International Regulatory Lead (Sr. Associate) is assigned to one or more Amgen products and may support an IRL or lead a program under the supervision of an experienced regulatory lead. + Execute the international **regulatory strategy** and regulatory plans. + Prepare supportive documentation for regulatory deliverables. + Support **regulatory product compliance** (e.g. RIM, PMCs, […]

Regulatory Affairs Analyst II

Wondering what’s within Beckman Coulter? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates […]

Regulatory Affairs CMC Manager – Beijing

Job Summary Regulatory CMC China Manager is responsible for execution of the China -specific product strategies align with the global strategy. This position prepares CMC relevant documents and submits CTNs / MAAs dossiers in collaboration with Global Reg CMC and Operations and may need support from the local Managers partially. This position provides CMC information […]

Senior Analyst Regulatory Affairs (m/f/d)

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that […]

Sr Associate Regulatory Affairs – based in Egypt

**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key […]

Sr Associate Regulatory affairs

**Regional Specific Activities** • Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements. • Contribute to and execute the filing plan for their country where applicable • Review source text for country labeling • Review promotion and non-promotion materials • Disseminate relevant information to team(s) as appropriate • Participate […]

Regulatory Affairs Senior Director – Global Regulatory Leader – Oncology

**HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that […]

Vice President Regulatory Affairs, Obesity

**HOW MIGHT YOU DEFY IMAGINATION?** At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the […]

Head of Regulatory Affairs Policy & Regulatory Intelligence

**HOW MIGHT YOU DEFY IMAGINATION?** At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the […]

Regulatory Affairs Manager – Regional Regulatory Lead

**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key […]

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