Director, Head of Regulatory Operations & Information Management, US - Remote
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.
Director, Head of Regulatory Operations & Information ManagementLive
What you will do
Lets do this. Lets change the world. In this vital role, you will lead the Global Regulatory Operations team in support of regulatory submissions and management of regulatory information worldwide. Engage on cross-functional teams to provide a strategy for the development and implementation of initiatives to improve processes and information/data quality and management
- Provide strategic leadership of Regulatory Operations core functions including Submissions Management & Publishing, Process & Systems Excellence, RIM, Data Quality & Analytics and Compliance including XEVMPD/IDMP
- Provide Regulatory Operations strategy to teams including dossier publishing, lifecycle maintenance, data exchange, and archival
- Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submissions and registrations
- Collaborate with cross-functionally internally and externally to GRAAS to ensure Regulatory Operations business needs are met
- Act as Business Process Owner for Regulatory Operations business processes/initiatives; Collaborate with other BPOs to resolve cross-functional challenges
- Lead strategy, implementation, and organizational change management related to new and existing Regulatory Operations processes, tools, and data across R&D
- Partner with DTI to develop and drive the multi-year roadmap for Regulatory Operations to increase speed, quality/compliance, and efficiency
- Drive and advance Regulatory Operations strategy to ensure usability, efficient data entry, quality, integration, and analytics
- Ensure effective Governance, Support and Change Management, and secure user consensus and adoption to ensure GRAAS captures the value/ROI of Regulatory Operations investments
- Build and leverage relationships with industry, vendor, and trade associations to influence future regulatory environment from a regulatory operations perspective
- Partner with Global Process Networks to ensure connectivity and continuous process improvement in cross-functional E2E processes
- Partner with Regulatory Operations partners/suppliers to influence future roadmaps to ensure ongoing successful and compliant support
Key Skills and Knowledge:
- Submissions and regulatory information management processes, tools/applications, governance, and support
- Drug registration procedures and dossier requirements worldwide
- Team Leadership, Coaching, and Mentoring
- Negotiation, Collaboration, and Persuasion
- Strong understanding of the impact of emerging regulatory registration requirements and their implications for Amgen
- Anticipating and resolving problems; critical thinking
- Communications and relationship building
- Strong knowledge of and vision for Regulatory Operations processes and document/data management
- Demonstrated excellence in project and change management and stakeholder engagement
- Inform, influence, and pivot based on stakeholder insight
- Identify and effectively communicate options, risks and mitigations and escalate risk judiciously
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a innovative leader with these qualifications.
Doctorate degree and 4 years of directly related experience OR Masters degree and 8 years of directly related experience OR Bachelors degree and 10 years of directly related experience
- 10 years of experience directly managing people and successfully leading cross-functional Regulatory Operations teams, projects/programs
- Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Data Management
- Strong people, communication, and matrix leadership skills
- Lean/Six Sigma or other process improvement methodologies
- Veeva System Admin certification
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.com
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.
We will ensure that individuals with disabilities are provided 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 accommodation.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.