Director, Cmc Regulatory Compliance

vor 1 Woche

Zürich, Zürich, Schweiz Takeda Vollzeit
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Director, CMC Regulatory Compliance employee

How you will contribute:

  • The Director of CMC Regulatory Compliance is responsible for the strategic and operational activities pertaining to global and local compliance within Global Regulatory Affairs
  • Chemistry, Manufacturing and Controls & Devices (GRA CMC).
  • Partners and influences cross functionally with colleagues in Quality Assurance, Compliance, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, and Local Operating Companies to drive compliance and continuous improvement.
  • Leads and manages Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and is a point of contact for Regulatory CMC on audits & Inspections
  • Develops and manages a program for the tracking, execution, monitoring, and reporting on GRA CMC processes (Metrics and KPIs) to drive excellence in Regulatory CMC pre and post submission activities.
  • Seeks opportunities to build optimized CMC capabilities through digital solutions and automation enablement for optimal execution and compliance.
  • Ensure Regulatory CMC is aligned with and responsive to health authority regulations and guidelines as they pertain to requirements for drugs, biologics, combination products and devices.
  • Collaborates across Global Regulatory CMC to ensure clear and timely communication about compliance risks, business processes, compliance activities and metrics.
  • Partner with CMC LT to support global strategic CMC initiatives related to pre and post submission activities and the processes and systems used to manage compliance.
  • Independently manages oversight of all Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and a robust compliance metrics review program.
  • Ensure CMC inspection readiness and act as a main point of contact with Global Quality and other stakeholders for internal and external audits
  • Ensure that responses resulting from audit and inspection findings and CAPAs related to GRA CMC are aligned with CMC LT and stakeholders.
  • Ensure GRA CMC Commitments (i.e. IND, post marketing) and Quality Events are managed within specified timelines.
  • Build effective relationships with GRA Compliance and other R&D Compliance departments to develop new and updated endtoend processes for execution of GRA pre and post submission activities.
  • Escalate issues/problems to CMC LT as needed and propose riskbased remediation actions for consideration
  • Provide input on budgets for the group as appropriate
  • Maintain strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory CMC.

_ CORE ELEMENTS RELATED TO THIS ROLE _

  • This role is best suited for someone with proven management experience of staff as well as influence in a matrix structure.
  • Knowledge of the pre and post submission regulatory requirements on major markets like EU, USA, Canada, U.K. and other international markets.
  • Operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multicultural environment.
  • This role is global and has crossfunctional collaboration across multiple parts of the Regulatory, Quality and R&D groups including TAU, MPG, Business Units, and CROs.
  • Quality System Management and Regulatory drug development experience are key for this role to be successful.
  • Systems Knowledge knowledge of Quality Management Systems including Deviation and CAPA management, SharePoint, and Regulatory Information Management (RIM).

_ DIMENSIONS AND ASPECTS _

Technical/Functional (Line) Expertise

  • Regulatory knowledge of European, US and international regulations relative to pre and post submission regulatory requirements.
  • Industry Knowledge strong understanding of the pharmaceutical industry and pharmaceutical companies' operations processes and strategies particularly Quality Management Systems, Drug Development, Regulatory Affairs, and Compliance.

Leadership

  • Demonstrated ability to work independently to inspire, motivate, and lead people across functions, regions, and cultures.
  • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
  • Ability to distil complex issues and ideas down to simple comprehensible terms
  • Demonstrates leadership presence and confidence
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Invests time in helpin

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