Executive Director Regulatory Affairs, Device Regulatory
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 demonstrates 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 increasingly using medical device technologies to aid in the identification and treatment of patients, and is committed to ensuring that the use of our products represents a positive experience for all end users. Our ability to rapidly and efficiently satisfy global medical device and combination product regulatory requirements is an essential enabler for these objectives.
The Executive Director Regulatory Affairs, Device Regulatory will report to the Vice President, Regulatory Affairs for CMC, Devices and Biosimilars. In this role the Executive Director will be responsible for regulatory strategies for device combination products (i.e., drug delivery) and other device technologies (i.e. in vitro diagnostics/companion diagnostics, software) in collaboration with Global Regulatory Affairs, Commercial, Development and Operations.
This position is located in Thousand Oaks, California.
- Provide clear vision and consistent expectation for the team
- Drive development of global regulatory plans and strategies; influence cross-program regulatory filing strategies
- Drive creation of effective and efficient processes, and refine existing processes to ensure consistency in submission preparation and (response to questions) RTQ preparedness
- Provide leadership, training, and development of Staff to enable successful Device Regulatory Leads
- Ensure timely updates to management, key stakeholders, and project teams
- Lead Health Agency cross-program contacts and meetings
- Perform cross-functional and Sr Management reviews prior to submission
- Direct and establish Amgen regulatory positions and communicate these to relevant partners
- Drive development of and own regulatory business process(es); participate in GRAAS process initiatives/councils
- Clearly identify functional responsibilities and focus resource on regulatory-specific results
- Participate in Amgen governance meetings with accountability as decision maker and or advisor
- Lead, perform or delegate external policy reviews for global regulatory guidance and regulations
- Support for supplier engagement teams and external due diligence regulatory activities
- Direct, develop, and deliver internal and external education and training activities
- Build and maintain effective relationships with internal and external partners
- Build the best teams through recruiting and developing staff
- Represent Amgen and influence policy at trade associations and external events (e.g., CPC, AdvaMed, PhRMA, PDA, BIO, DIA, AAMI, ISO), as appropriate
- Doctorate degree & 6 years of Regulatory Affairs experience OR
- Master’s degree & 10 years of Regulatory Affairs experience OR
- Bachelor’s degree & 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
- Degree in Regulatory Affairs, Life Sciences, Engineering or related field
- Experience in Regulatory Affairs, including United States and international medical device, combination product and/or companion diagnostic regulations
- 12+ years of industry related technical/development experience in medical devices, combination products and/or companion diagnostics
- Additional skills to include: decision making and prioritization, ability to work cross functionally with an emphasis on teamwork and collaboration, knowledge of regulatory interpretation and clinical case assessments, demonstrated ability to effectively lead an organization
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 understands 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 organization’s internal capabilities and skillsets, including strategic external recruiting
- Identifying diverse, qualified successors for key positions
- Ensuring that team leaders who also lead people consistently demonstrate these same behaviors with their 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.
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 understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
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.
Learn more here
Job posted: 2020-12-23