Director, Regulatory

3 weeks ago

Cambridge Cambridgeshire, United Kingdom Amgen SA Full time

Our shared mission—to serve patients—has driven our status as one of the world’s 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.
SENIOR DIRECTOR EUROPEAN REGULATORY AFFAIRS - OBESITY
As a part of the EU Regulatory Affairs function, you will provide strategic leadership in aligning EMA regulatory requirements with Amgen’s corporate standards. Your responsibilities will include planning and managing EMA regulatory submissions, additionally, you will act as the primary point of contact with the EMA.
Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements
Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
Monitor the external regulatory environment to help inform in the decision making
Lead and / or strategically support regulatory product compliance (e.g. Lead the regulatory submission of urgent safety communications, DHPCs & DILs as required by Amgen SOPs or local regulatory requirements, as needed
Provide leadership guidance to Global teams on local regulatory implications and requirements relevant to the global clinical development/Marketing Applications plans and objectives
As part of the Global Regulatory Team (GRT), provide direction and expertise on local regulatory mechanisms to optimize product development
Act as the point of contact with EMA in fulfilling local obligations
REGULATORY RESEARCH
Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to Amgen products
Perform regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement
Monitor and influence European regulatory guidance on Obesity products in support of the advancement of Amgen’s portfolio
Mentor and lead performance management tasks for direct reports, including robust talent management
Demonstrated ability in European regulatory affairs, supporting & leading teams dealing with complex submissions
In-depth regulatory experience working with the EMA
Strategic Lead – proven ability to develop and adapt robust regulatory strategies
Knowledge of regulatory principles, working with policies, procedures, and SOP’s
Comprehensive understanding of regulatory activities and how they impact other projects and/or processes
Awareness of the registration procedures/challenges for CTAs, MAs and all lifecycle management activities
Ability to anticipate regulatory Agency questions and potential response
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
LOCATION Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
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.
lease contact us to request an accommodation.
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