Business Process Owner - Regulatory Affairs, Senior Manager

Thousand Oaks, CA, US
Sep 10, 2019
Required Education
High School or equivalent
Position Type
Full time
Amgen is hiring a Business Process Owner, Regulatory Affairs Senior Manager for our Thousand Oaks, California campus, other sites within the US or UK may be considered.

Global Regulatory Affairs develops regulatory strategies, gains and maintains regulatory agreements with global health authorities to allow the appropriate use of our products.

The Business Process Owner, Regulatory Affairs drives compliant Global Regulatory Affairs Process in support of Amgen's strategic imperatives and external drivers by:
  • Leading and driving Amgen's Regulatory Process Network
  • Developing and maintaining effective Global Regulatory Processes
  • Driving operational excellence by applying continuous process improvement methodology
  • Driving consistency and best practice sharing across regions, countries and sub-functions of Global Regulatory Affairs

Key Activities
  • Business Process Owner (BPO) for global Regulatory Affairs business processes; develop the continuous improvement project portfolio; manage strategy and tactics of this portfolio consistent with business priorities
  • Drive the creation and updates of the Global Regulatory Affairs process by leading, liaisoning, and supporting subject matter experts in process creation/ updates.
  • Drive Global Regulatory Affairs process excellence by leading and implementing continuous improvement efforts to best in class efficient compliant processes.
  • Lead Global Regulatory Affairs deviation management by partnering with compliance to manager deviations/ CAPAs through completion.
  • Provide guidance on process support needs, issues and proposed resolution, and guidance on process issues to the Global Regulatory Affairs Senior Management Team.
  • Own and manage the assignment of training and controlled documents (SOPs, etc.) for Global Regulatory Affairs.

Knowledge and Skills
  • Knowledge of quality management principles including continuous improvement methodologies
  • Knowledge of GxP
  • Knowledge of FDA, EMEA, and other international regulations
  • Leadership skills
  • Strategic thinking
  • Creative problem solving
  • Project management
  • Ability to prioritize competing objectives
  • Written and verbal communication skills
  • Presentation and negotiation skills
  • Ability to build strong relationships, influence others, and work cross-functionally
  • Interpersonal, organizational, and supervisory skills
  • Microsoft Suite: eg Word, Excel, PowerPoint, etc.

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

Basic qualifications
Doctorate degree & 2 years of R&D Pharmaceutical/Biotech experience
Master's degree & 6 years of R&D Pharmaceutical/Biotech experience
Bachelor's degree & 8 years of R&D Pharmaceutical/Biotech experience
Associates degree & 10 years of R&D Pharmaceutical/Biotech experience
High school diploma / GED & 12 years of R&D Pharmaceutical/Biotech experience

Preferred qualifications
  • Prior work experience at Amgen
  • Experience in Regulatory Affairs for Pharma/Biotech

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need 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.

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.

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.