Sr Manager, Global Regulatory Operations; Head - Regulatory Systems (Remote Option)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
Sr Manager, Global Regulatory Operations; Head - Regulatory Systems (Remote Option)Live
What you will do
Lets do this. Lets change the world. In this vital role you will deliver regulatory systems to enable compliance with evolving regulations and Amgens strategic initiatives for innovation.
- Drives the timely, efficient and compliant life cycle management of regulatory systems (eg. Veeva Vault-RIM, Appian, etc.).
- Enables continuous improvement by leveraging the existing and future regulatory system landscape to bring new capabilities in support of strategic and external drivers (eg. new regulations)
- Lead and execute multiple Vendor and Amgen-driven system upgrades in compliance with Regulations.
- Drives the alignment and execution of system impact assessments related to upgrades; and contributes to related process and training documentation
- Contributes to cross-functional governance of business critical regulatory systems (eg. Veeva Vault-RIM, Appian, etc.)
- Leverage industry, vendor and regulatory agency trade associations and governance to influence future regulatory environment (i.e. Round Tables, Symposia, Heath Authority pilots, etc.)
- Partners with vendors to influence road map and ensure successful and compliant system life cycle management
- Provide tools, process and resources to supervise adherence to key internal regulatory processes (i.e. network compliance indicators, data quality reports, etc.)
- Run technology assessments as required
- Lead the recruitment, training, and development of Regulatory System Staff
- Lead the day to day operations of Regulatory Systems team
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The dynamic professional we seek is a mentor with these qualifications.Basic Qualifications
- Doctorate degree and 3 years of related experience OR
- Masters degree and 5 years of related experience OR
- Bachelors degree and 7 years of related experience OR
- Associates degree and 10 years of related experience
- Experience either directly managing people, or leading teams, projects or programs including directing allocation of resources (5+ years preferred)
- Pharmaceutical/Biotech industry experience in an operationally focused role (within Regulatory Affairs or R&D)
- Direct experience with data/document management systems including governance, international data standards, reporting, analytics, integrations and data lakes
- Broad working knowledge of Regulatory submissions supporting global Clinical Trial Applications, Marketing Authorizations and other Regulatory registrations
- Experience with Veeva Vault systems, Submission Publishing systems and/or Appian are preferred
- Familiarity with current evolving Regulations (eg. EU CTR, IDMP) and understanding of GXP system requirements; 21 CFR Par 11
- Management and implementation of system upgrades to support the ongoing system lifecycle
- Development of business user requirements supporting system configurations through Agile methodology
- Participation in vendor, industry or Health Authority trade associations
- Experience interacting with regulators during inspections would be an asset
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 health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.comEqual Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request an accommodation.
Join UsIf 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.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.