Amgen

Global Regulatory and R&D Policy Director - Biosimilars

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 10, 2019
Ref
R-74032
Required Education
Bachelors Degree
Position Type
Full time
The Global Regulatory and R&D Policy team advances important policy issues, aligned with Amgen's goals and priorities, by engaging regulators, industry and professional associations, patient advocates, and internal subject matter experts across Amgen.

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.