Amgen

Executive Director, Global Regulatory Affairs

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Jun 03, 2021
Ref
R-119557
Required Education
Bachelors Degree
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Global Regulatory Affairs

Live

What you will do

Lets do this. Lets change the world. In this vital role you will join us as we Accelerate in our Fight for Patients by leading our Global Regulatory Affairs Execution Team (GRAET).

This individual will report to the Senior Vice President for Global Regulatory Affairs and Strategy (GRAAS), and will be accountable for the efficient and compliant execution of all Regulatory Operations, Regulatory Writing, and Labeling processes across all products.

The Head of GRAET will be a key member of the GRAAS Executive Leadership Team, ensuring that Amgens product goals and ambitions are met in the most efficient way, while maintaining compliance with all applicable rules and regulations. This role will also play a significant part in advancing GRAASs vision of using Knowledge Management to increase speed, reduce workload, and deliver for our patients worldwide. Finally, the Head of GRAET will also be a key leader in our efforts to apply continuous improvement principles to our Regulatory practices, extending beyond the teams that the role will directly lead.

The successful candidate in this role will have a deep understanding of how the work of Regulatory Affairs gets done. They will have a proven track record of managing a diverse set of processes, while simultaneously identifying and implementing process improvements to yield either/both cycle time gains and cost reduction from those processes. The candidate will also have experience managing a mixed internal/outsourced workforce and will be able to think strategically about how the mix of resources can be adjusted to deliver on corporate goals and objectives.

GRAASs vision is to unlock the availability of Amgen's therapies around the world. We do this by creating and executing regulatory strategies to expeditiously obtain and maintain product licenses globally. GRAAS operates in 40+ countries around the world, and its nearly 900 staff interact daily with hundreds of vendors, contractors, and outsourced workers to execute these strategies and serve Amgens patients.

Responsibilities of this role include:

  • Accountable for all aspects of Regulatory Labeling, Global Regulatory Operations, and Global Regulatory Writing
  • Represent the GRAET functions to GRAAS and Amgen Senior Management
  • Provide timely input on GRAAS and Amgen Senior Management on strategies, decisions, and implementation plans related to the GRAET functions
  • Define departmental goals and objectives, and lead team to achievement of them
  • Provide strategic vision to guide the continuous improvement of GRAET activities, delivering year-over-year productivity savings
  • Partner with cross-functional leadership to resolve conflicts and prioritize activities in alignment with Amgens and GRAASs strategic goals and imperatives
  • Provide coaching, mentoring, and development of staff
  • Recruit and retain regulatory professionals and assist in the recruitment of talented GRAAS and Amgen staff
  • Ensure staff are compliant with Amgen corporate and departmental training and SOP review
  • Establish and maintain an appropriate balance between internal (RFT) and external (CW/outsourced) workforces to maximize efficiency and meet Amgens strategic objectives
  • Sponsor and/or lead process improvement projects related to the GRAET functions
  • Advance Knowledge Management as a core competency and driver of efficiency/success across GRAAS

Win

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 Leader with these qualifications.

Basic Qualifications:
  • Doctorate degree and 6 years of regulatory affairs experience OR
  • Master's degree and 10 years of regulatory affairs experience OR
  • Bachelor's degree and 12 years of regulatory affairs experience AND
  • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • MBA., PhD, PharmD, Masters Degree
  • 10 years of work experience in life sciences or medically related field, including 7 years of research and development experience in biopharmaceutical or pharmaceutical industry

Thrive

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.

  • Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
  • 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

Amgens Commitment to Our Staff

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 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
  • Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
  • Resolving critical gaps in the organizations internal capabilities and skillsets, including strategic external recruiting
  • Identifying diverse, qualified successors for key positions
  • Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff

We understand that to successfully sustain and grow as a global enterprise and deliver for patients we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

MEANINGFUL IMPACT. To serve patients. We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.

INNOVATIVE: Stretch yourself at the cutting edge. Youre poised to have a high impact in the new Bio century, Amgen offers our people interesting and challenging work.

REPUTATION. Be behind world-renowned products and services. With our industry reputation and strong product pipeline, you can take pride in working at Amgen.

COLLABORATIVE. Work alongside the best. Be part of our highly talented, hard-working teams. Their spirit is what fuels our success.

REWARDING. Get a fair share in success. Everyones contribution is recognized and strong performance is rewarded.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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 you without regard to your 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.


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.