Regulatory Affairs Manager - Pediatric and Maternal Team

Amgen is seeking a Regulatory Affairs Manager-Maternal and Pediatric Team to join our team and work from Amgen's beautiful Thousand Oaks, CA campus. This position will report to the Medical Director. To learn more about this position:

The Maternal and Pediatric Team provides scientific and regulatory consultation to all product teams to guide them in the strategic development of Pediatric programs. Additional activities involve maternal health issues including the development and management of pregnancy registries and providing insight on novel strategies to gain insight on medication exposures during pregnancy.

Responsibilities of the Regulatory Affairs Manager include:

• Provide strategic vision and planning to organize the Maternal and Pediatric Team and extended network
• Organize and facilitate quarterly and ad hoc global meetings
• Manage the pediatric dashboard for all product teams to keep senior management informed of global pediatric activities
• Creation and collection of Metrics
• Track current pediatric projects, filings and studies
• Maintain database for pediatric-specific filings and regulatory submissions
• Create and manage presentations to orient various teams on pediatric drug development strategies and requirements
• Educating newly formed product teams about pediatric requirements and opportunities
• Provide research on development pathways and strategies for product teams
• Engage external pediatric cooperatives and assist with contracting; review and archive external pediatric cooperatives meeting minutes
• Review pediatric regulatory submissions i.e.: PIP, PSP, PPSR, etc.
• Manage Amgen Pediatric Network SharePoint site

Basic Qualifications:

Doctorate degree

OR
Master's degree and 3 years of Project Management and/or Clinical and/or Regulatory experience
OR
Bachelor's degree and 5 years of Project Management and/or Clinical and/or Regulatory experience
OR
Associate's degree and 10 years of Project Management and/or Clinical and/or Regulatory experience

Preferred Qualifications:

• AS Degree
• 3+ years of Scientific experience
• 3+ years of Project Management experience
• Clinical/Pediatric experience
• Ability to educate teams on process and pediatric needs
• Regulatory experience

Amgen provides a collaborative and creative culture in a company with a strong track record of innovation. Our culture encourages open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow.

Amgen focuses on areas of high unmet medical needs and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

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.