Global Regulatory and R&D Policy Director - Biosimilars
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Oct 10, 2019
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
Amgen is seeking a Global Regulatory and Policy Director to work out of our Thousand Oaks, CA office. This position will report to the Executive Director, Global Biosimilars and JAPAC Regulatory Policy.
The team leads and/or participates in developing, advocating for, and implementing Amgen's positions on regulatory policies that impact Amgen's business. The team works with cross-functional colleagues to develop strategic policy plans to advance regulatory policy issues and engages regulatory authorities, industry, and professional associations on policy issues.
The responsibilities of the position include:
- Providing strategic regulatory and R&D policy advice and guidance on a range of issues related to Amgen's product portfolio
- Leading and/or participating in developing and successfully advancing Amgen's regulatory, safety, and R&D policy positions, with an emphasis on Amgen's iosimilars products and other technical regulatory policy issues
- Assisting and advising executive leadership on regulatory and R&D policy issues, including establishing priorities, and developing and executing regulatory policy advocacy plans
- Fostering a reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies
- Leveraging understanding of regulatory health authorities (e.g. FDA, EMA), industry trade associations, and other relevant organizations, to advance Amgen's position related to regulatory and safety policy, with an emphasis on Amgen's biosimilar policy
- Providing internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Value & Access, Legal) with a strategic regulatory and safety policy perspective on key issues
- Monitoring, analyzing, and anticipating changes in the regulatory environment, including their impact to Amgen's policy strategy, with an emphasis on Amgen's biosimilars products
Basic Qualifications
Doctorate degree and 4 years working in a pharmaceutical /biotech industry or health agency with regulatory/policy or legal experience
OR
Master's degree and 8 years working in a pharmaceutical /biotech industry or health agency with regulatory/policy or legal experience
OR
Bachelor's degree and 10 years working in a pharmaceutical /biotech industry or health agency with regulatory/policy or legal experience
Preferred Qualifications
- BS Degree
- 12+ years' experience in pharmaceutical /biotech industry
- Experience in building relationships with key stakeholders (e.g., trade associations, bio-pharmaceutical companies, FDA, EMA, other national competent authorities)
- Proven strategic and analytical abilities
- Knowledge of regulatory, R&D, safety, and drug development issues, including a strong background in biosimilars issues
- Experience in policy development
- Experience with biosimilars regulatory and R&D issues
- Strong presentation and interpersonal communication skills
- Comprehensive knowledge of the bio-pharmaceutical industry, including development and execution of regulatory policy strategic plans
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.
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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