Regulatory Affairs Global Senior Vice President

My client is dedicated to improving the lives of patients battling serious and rare diseases. They have retained our firm to find a Senior Vice President of Global Regulatory Affairs to be a strategic, dynamic, and successful senior executive during this critical phase of the company’s growth. You will provide visionary leadership and insight into key regulatory functions, while advancing vital rare disease treatments. With their first FDA approval expected this year, now is an ideal time to join this growing organization.

Responsibilities:

  • Provide overall leadership and global regulatory guidance.
  • Ensure successful negotiation strategies and execution of interactions with regulatory agencies in the US and Europe and Asia Pac.
  • Develop strong and productive working relationships with key stakeholders.
  • Oversee and lead preparations of effective presentations to regulatory authorities.
  • Review and endorse key development documents.
  • Provide strategic direction to ensure optimal product approval and commercial success.
  • Proposes Regulatory consultancies/advisory boards across based on clear objectives; supports the conduct of such processes.
  • Ensures representation as needed in governance or strategic teams or committees.
  • Successful creation and submission of Regulatory dossiers such as NDAs and MAAs and JNDAs.
  • Hires, develops, and leads a strategic team to build the company as it evolves through approval, prelaunch, and launch activities.

Knowledge and Skills:

  • MD or PhD preferred, with significant industry experience, specifically in the orphan drug space
  • Successful steering of critical filings, including negotiating, revising, and leading through submission and approval phases.
  • Significant direct experience in dealing with FDA, EMA, PMDA and other agency liaison activities
  • Successful creation and submission of Regulatory dossiers such as NDAs and MAAs and JNDAs is critical.
  • Experience in the infectious diseases arena preferred.
  • Successful steering of critical filings, including negotiating, revising, and leading through submission and approval phases.
  • Strong regulatory knowledge of drug development, clinical trial requirements, design and analysis, post-marketing surveillance, manufacturing (ideally with drug- device combinations), quality, marketing and sales.
  • Must have excellent communication skills (verbal and written)
  • Strong, organized leader with strategic vision who sets clear goals
  • Has experience building high-performance teams
  • Flexible in approach, entrepreneurial by nature and a collaborative team player

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