Merck KGaA Darmstadt Germany-posted about 1 year ago
$173,900 - $260,900/Yr
Full-time • Senior
Remote • Billerica, MA
Chemical Manufacturing

The Director of Global Regulatory Affairs will represent Regulatory Affairs in Global Project Teams, leading the regulatory sub-team and ensuring alignment with global regulatory strategies. This role involves driving the regulatory submission process, managing high-quality documentation, and coordinating major regulatory agency interactions. The position requires strategic development of regulatory plans aligned with project goals and effective management of project resources within a matrix leadership framework.

  • Represent Regulatory Affairs in Global Project Teams for assigned projects.
  • Lead the regulatory sub-team (GRST) and ensure alignment with global regulatory strategy.
  • Drive the regulatory submission process, managing and coordinating high-quality documentation and deliverables.
  • Ensure optimal management of major regulatory agency interactions, including preparation of briefing materials and coordination of rehearsals.
  • Develop regulatory strategies aligned with project development plans.
  • Ensure effective management of project resource requirements within the GRST through matrix leadership.
  • Participate in cross-functional and Global Regulatory Affairs initiatives.
  • Advanced degree with at least 5 years of relevant experience.
  • Minimum of 3 years of recent oncology experience.
  • Proven strategist with successful interactions with FDA or EMA.
  • Strong matrix leadership skills.
  • Excellent spoken and written English.
  • Medical, vision, and dental insurance
  • Life insurance
  • Disability insurance
  • 401(k) matching program
  • Paid time off
  • Paid holidays
  • Short-term or long-term incentive compensation, including cash bonuses
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