Amgen Regulatory Affairs Manager in Breda, Netherlands
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 becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:
REGULATORY AFFAIRS MANAGER
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
The Regulatory Affairs, Manager will provide expertise in translating chemistry, manufacturing and control (CMC) regulatory requirements into practical, workable plans. The primary responsibilities of this role are to support the planning and execution of the site-specific aspects of the preparation of CMC sections for new marketing applications, and post-market supplements, organization and preparation CMC sections of annual reports of minor changes for specific products. You will act as key Regulatory Affairs CMC representative for managing change control and deviations and serve as the CMC point of contact for communications with business partners and global regulatory authorities for requests related to the site.
Let’s do this. Let’s change the world. In this vital role you will:
Support the develop and implementation of CMC regulatory strategies as they relate to changes at the site.
Provide strategic expertise regarding CMC regulatory requirements for manufacturing related projects.
Coordinate activities with Global and International CMC representatives.
Interface with Regulatory Authorities as appropriate and in coordination with Global and International CMC representatives.
Support regulatory authority inspections as directed by Site Quality Compliance.
Serve as Regulatory Affairs - CMC representative on Cross Functional Teams.
Lead or collaborate in the creation site related regulatory components for global CMC submissions.
Support the generation of facility and GMP related documents to be used in product registrations activities.
Review and approve regulatory documents.
Review and assess the regulatory impact of proposed manufacturing related changes, deviations and other GMP related documents.
Maintain facility related CMC files.
Develop and maintain regulatory awareness through meetings, conferences and regulatory contacts.
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 a strong communicator with these qualifications:
- Doctorate degree and 2 years of directly related experience
- Master’s degree and 6 years of directly related experience
- Bachelor’s degree and 8 years of directly related experience
Educational background (Bachelor, Master or Doctorate degree) in Biotechnology, Microbiology, Chemistry or equivalent is preferred.
Experience in manufacturing, testing (QC/QA or clinical) or distribution in Pharmaceutical or Biotech industry.
Strong communication skills in English and preferably Dutch
Strong negotiating and leadership skills
Experience managing project timelines is desirable
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.
Vast opportunities to learn and move up and across our global organization.
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.
- Due to our relocation policy, for this vacancy, we can only consider candidates who reside in the Netherlands or candidates who live on a commuting distance from Amgen Breda.
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.