Regulatory Policy Senior Manager

HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. 

REGULATORY POLICY SENIOR MANAGER, ELMAC (Europe, Latin America, Middle East, Africa and Canada).

LIVE

What you will do

The Global Regulatory Policy engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues.

In this vital role you will contribute to the development and execution of Amgen's positions on regulatory policies that impact Amgen's business and will report to the Amgen’s Executive Director, ELMAC & JAPAC Lead, in Global Regulatory Policy and Intelligence. 

Key Responsibilities include:

• Contribute to the development and execution of strategic plans for each assigned policy area. Master a range of regulatory and R&D policy topics as assigned.
• Support policy leads in ELMAC in providing strategic regulatory and R&D policy advice and guidance on a range of issues related to Amgen’s product portfolio
• Lead and/or participate in developing and successfully advancing Amgen's regulatory and R&D policy positions 
• Investigate policy research questions and conduct analyses, contribute to internal cross-functional teams, coordinate tasks with team members and across organizations, and support external engagement. 
• Foster a reputation with regulators as being science-based, reliable, and trustworthy by advocating for sound regulatory policies 
• Leverage understanding of regulatory health authorities (e.g. EMA), industry trade associations, and other relevant organizations, to advance Amgen's position related to regulatory policy 
• Provide internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective. Partner with policy leads to develop whitepapers, policy analysis documents, and advocacy materials on priority policy issues
• Monitor, analyze, and anticipate changes in the regulatory environment, including their impact to Amgen’s policy strategy 
• Plan and help manage projects for agreed upon policy objectives under the direction of in partnership with policy lead(s). 
  

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory policy and intelligence professional we seek has a deep knowledge and understanding of the EU. and global regulatory environment and can shape the external regulatory environment to support Amgen priorities and has these qualifications:
Basic Qualifications:
•    Degree educated in biology, chemistry, or life science.
•    Demonstrable regulatory experience, including knowledge of EMA, or other international biopharma regulatory policy.
•    A strong team player with a demonstrated track record of working collaboratively across functional areas.
•    Strong oral and written communication skills.

Preferred Qualifications:
•    Experience in building relationships with key stakeholders (e.g., trade associations, biopharmaceutical companies, EMA, other national competent authorities)
•    Proven strategic and analytical abilities
•    Knowledge of regulatory, R&D, safety, and drug development issues
•    Experience in policy development
•    Strong presentation and interpersonal communication skills
•    Comprehensive knowledge of the biopharmaceutical industry, including development and execution of regulatory policy strategic plans
•    Demonstrated ability to work well with people at all levels of an organization in demanding situations with a positive attitude, tact, diplomacy, and respect.
•    Demonstrated ability to work in a fast-paced environment while retaining a high attention to detail and quality.

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.

• Vast opportunities to learn and move up and across our global organization
• 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

LOCATION Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.

Apply now

for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, 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.