Director, Global Regulatory Affairs CMC - Biologics (Hybrid)

Company: Takeda
Location: Lexington
Posted on: November 20, 2023

Job Description:

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Job Description

Join Takeda as a Director, of Global Regulatory Affairs CMC where you will oversee the development and execution of regulatory CMC development and registration strategies. You may manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.

How you will contribute:

• Demonstrate Takeda leadership behaviors.
  
• Manage and lead a team to prepare regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
  
• Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
  
• Evaluate change proposals for regulatory impact and filing requirements.
  
• Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and will review this content for conformance with established requirements.
  
• Lead and contribute to business process development.
  
• Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.
  
• Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.
  
• Ensure that project team colleagues, line management, and partners are informed of developments that may affect regulatory success.
  
• Elevate and communicate actual or potential issues to line management.
  
• Successfully communicate and negotiate with international Health Authorities, directly and indirectly.
  
• Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.
  
• Manage and support staff, if required, including staff professional development and project oversight.
  
  
  What you bring to Takeda:
  
  
  • BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
    
  • 10+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred.
    
  • Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
    
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
    
  • Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
    
  • Ability to deal with issues of critical importance provides regulatory advice and makes reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
    
  • Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
    
  • Good judgment in elevating and communicating actual or potential issues to line management.
    
  • Excellent written and oral communication skills.
    
  • Experience of active participation in Agency/Industry groups/forums expected.
    
    
    Travel Requirements:
    
    
    • Willingness to travel to various meetings, including overnight trips.
      
    • Requires approximately up to 10-30% travel.
      
      
      EEO Statement
      
      Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
      
      Locations
      
      Lexington, MA
      
      Worker Type
      
      Employee
      
      Worker Sub-Type
      
      Regular
      
      Time Type
      
      Full time

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