Amgen Senior Associate Regulatory Affairs in Breda, Netherlands
Amgen is one of the world’s leading biotechnology companies with a powerful sense of shared purpose toward our mission: To serve patients. We provide the resources and rewards of a global company, while maintaining the entrepreneurialism and pioneering spirit as a value-based health care innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities.
Do you want to be part of an innovative biotech company that is working with an enthusiastic team towards successful treatments for patients? The Dutch affiliate wants to strengthen its Regulatory Affairs team with a Senior Associate Regulatory Affairs.
In this role it is your responsibility to:
Provide national regulatory affairs expertise on assigned Amgen products
Plan and manage local regulatory submissions in compliance with Amgen and national regulatory requirements
Review and approve source text for country labeling and own country artwork based on source text
Review promotional materials
Act as a regulatory advisor for local medical and commercial teams
Act as a regulatory advisor on national laws and regulations for regional and global teams
Act as the point of contact with regulatory agencies
Act as a back-up for the RA Lead
Furthermore, in this role:
You monitor the external regulatory environment and forwards information to local/regional groups communicating the impact to Amgen.
You work closely with cross-functional colleagues in the affiliate to align on strategy and deliver affiliate goals.
You exchange regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations/regulations in a timely manner.
You partner with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of assigned Amgen molecules.
You participate in local regulatory process improvements, initiatives and training.
What do you need to be successful in this role?
You have a master’s degree (scientific area, e.g. pharmacy) or bachelor’s degree (scientific area) and 2 years of directly related experience.
You have Knowledge of Regulatory principles.
You have general knowledge of national legislation and regulations relating to medicinal products and understanding of drug development.
You have experience working with policies, procedures and SOP’s.
You are fluent in Dutch and English (both oral and written)
You have attention to detail
You are eager to learn and have a ‘can do’ attitude.
An inspiring work environment with a focus on vitality (on site gym)
In house catering service with a wide variety of (healthy) food
A competitive base salary, bonus structure, 13th month, Long Term Incentives
A career development program
The recruitment process consists of resume screening, phone screening, online assessment and face to face interviews with a diverse set of stakeholders.
For this position we only consider candidates who live on a commuting distance from our Breda office, no relocation fee is offered for the position
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.