Amgen

Regulatory Affairs Manager - Pediatric and Maternal Team

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Aug 09, 2019
Ref
R-78020
Required Education
Bachelors Degree
Position Type
Full time
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.

At Amgen, our mission is serving patients. Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

Consistent with our core leadership value of "Develops the Best Team," we are seeking leaders that prioritize the development of talent. As a manager, your first priority and primary role is to accelerate the performance and development of your team. We expect managers to exemplify strong leadership and champion self-awareness and career development. Ways that you will display your leadership acumen in this role include:
  • Mentoring, coaching, and developing staff to build highly-skilled, diverse, and inclusive teams
  • Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities
  • Ensuring that staff understand how their efforts and contributions make a meaningful impact to the business
  • Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement
  • Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages
  • Developing an understanding of your team's career objectives and serve as a thought-partner in their career development plans


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 or more years of Scientific experience
  • 3 or more 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.

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.

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.

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.