Global Regulatory Operations Manager - Submission Management
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Global Regulatory Operations Manager - Submission ManagementLive
What you will do
Lets do this. Lets change the world. In this vital role you will ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities. Bring strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions.
- Supports or leads the tactical execution and detailed deliverables to support a Global Regulatory Filing within a regional/multi-regional filing plan.
- Lead the functional areas of the department and outsourced resources
- Take part in the career and skills development of staff members
- Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
- Lead the preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards
- Lead the creation and submission of regulatory dossiers across regions according to local requirements and agreed upon timelines
- Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
- Contribute to the development of the strategy for communicating with global health authorities
- Represent departmental expertise on global work streams
- Initiate, lead and manage process development and improvement
- Lead information system and software update projects as well as ongoing system validations from a publishing perspective
- Develop and report publishing metrics to senior management
- Provide technical support for regulatory systems
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a leader with these qualifications.
- Experience working in and leading teams
- Knowledge of the industry and business principles for a regulatory operations department
- Maintaining relationships with contributing functions and affiliates
- Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
- Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications
- Strong project management skills specifically related to regulatory projects
- Expert knowledge of eCTD, eCTD Specifications and eCTD software
- Expert knowledge of Emerging Markets Marketing Application submission requirements, country specifications, and software used
- Expert knowledge of International Clinical Trial and Paediatric submission requirements, country specifications, and software used
- Expertise in MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, improve your expertise, and increase your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
- Doctorate OR
- Masters degree and 3 years of directly related experience OR
- Bachelors degree and 5 years of directly related experience OR
- Associates degree and 10 years of directly related experience Or
- High school diploma / GED and 12 years of directly related experience
- Experience in a regulatory operations-focused role
- Experience liaision with global regulatory authorities as it pertains to regulatory submissions
- Expert knowledge in regional agency requirements for submissions
- Expertise with standard software used by regulatory publishing groups
for a career that defies imagination
Objects in your future are closer than they appear. 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, Puerto Rico and Canada 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.