Amgen Sr Associate Regulatory Affairs (CMC) in Breda, Netherlands
You’ve earned your degree and are shaping your early career. Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen our shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role:
Senior Associate Regulatory Affairs (CMC)
At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 38 different nationalities are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.
What you will do
As Senior Associate you will get the opportunity to shape your career within regulatory affairs. You will support the Regulatory Affairs Manager in the coordination, development and/ or execution of CMC regulatory registration activities in accordance with Amgen’s commercialization strategies and global regulatory plans. The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the CMC registration activities, including facility registrations, working in close collaboration with Site, Global and International CMC and with other functional areas within the site, other Amgen facilities and business partners.
Let’s do this. Let’s change the world. In this vital role you will:
Support the on-site regulatory affairs staff, collaborate with the Amgen product teams, regional offices, and/or site teams for specific strategies or activities that impact product registrations.
Facilitate product development by supporting global registration and life-cycle management for Amgen products.
Works cross functionally with local and global operations and regulatory personnel to coordinate preparation of regulatory filings and other documents used for registration purposes including: New marketing applications; Facility Registration documents; Annual report of minor changes; CSD Requests.
Lead the coordination of registration sample requests, including the resolution of issues that can impact execution.
Own and maintain SOPs and GDEs related to regulatory registration support activities.
Works within Amgen systems for document management and change control management.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory affairs professional we seek is eager and a good communicator with these qualifications:
Master’s degree or Bachelor’s degree & 2 years of regulatory affairs experience.
Educational background in Biotechnology, Microbiology or Chemistry is preferred.
Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry.
Strong oral and written communication skills in English and preferably Dutch.
Proficiency working with teams at different levels and company locations
Able to operate in a fast paced, dynamic environment
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is recognized as World's Best Workplace 2021 (ranking: #8).
Full support and resources to expand your skills, enhance your expertise, and maximize your potential along your career journey.
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.