Senior Director European Regulatory Affairs

Senior Director European Regulatory Affairs

Amgen

London or Cambridge, United Kingdom

What you will do

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.

Responsibilities and activities

STRATEGY AND EXECUTION

  • Develop a robust European strategy for specific products or disease areas assigned [Obesity] aligning with the GRL(s) and cross functionally to identify the best strategy that will lead to European patient access
  • Contribute to and independently execute the filing plan for 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. IMR, PMCs, paediatric and other agency commitments)
  • 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

HEALTH AUTHORITY INTERACTIONS

  • Act as the point of contact with EMA in fulfilling local obligations
  • Provide strategic contributions to /EMA agency interactions and their preparation
  • Develop key relationships with the EMA and national agency cardiovascular/obesity experts where possible

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

LEADERSHIP AND MENTORING

  • Lead and develop high performing team focused in the disease area
  • Mentor and lead performance management tasks for direct reports, including robust talent management

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

  • Degree educated or equivalent
  • Demonstrated ability in European regulatory affairs, supporting & leading teams dealing with complex submissions
  • In-depth regulatory experience working with the EMA
  • Specific Therapeutic Area experience and expertise in the Cardiovascular/Obesity disease area
  • Strategic Lead – proven ability to develop and adapt robust regulatory strategies

GENERAL REQUIREMENTS

  • 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
  • Good knowledge of relevant legislation relating to medicinal products
  • Awareness of the registration procedures/challenges for CTAs, MAs and all lifecycle management activities
  • In depth understanding of drug development
  • Ability to anticipate regulatory Agency questions and potential response

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