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Eu Regulatory Affairs Senior Manager (Biosimilars)

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Amgen

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Location:
United Kingdom , Uxbridge

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Responsibility:

  • Plan and manage regulatory submissions for products within Amgen's biosimilar portfolio in compliance with global filing plans and local regulatory requirements
  • Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
  • Lead development of regional regulatory documents and meetings in accordance with GRT strategy
  • Provide regulatory direction on regional regulatory mechanisms to optimize product development
  • Participate in the development and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Consistent with GRT strategy, advise on regulatory implications and requirements related to regional development plans and objectives
  • Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
  • Ensure and lead regulatory compliance for biosimilar products (eg, agency commitments)
  • Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and long-term planning

Requirements:

  • Degree educated in a scientific discipline
  • Extensive experience of the regional Biosimilars regulatory environment
  • Proven track record of developing and executing regional Biosimilars regulatory strategy
  • In-depth understanding of the drug life cycle and development process from a regulatory perspective
  • In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
  • Ability to lead teams and work collaboratively in a dynamic environment
  • Proactive approach to problem solving
  • Ability to understand and communicate scientific/clinical information
  • Ability to anticipate regulatory agency expectations
  • Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
What we offer:
  • Growth 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

Additional Information:

Job Posted:
May 17, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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