Regulatory Affairs Director/ Sr. Director

My client is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening rare and genetic disease.  They have retained us for a Director (or) Senior Director of Regulatory Affairs to lead the development and execution of regulatory plans for assigned programs.  In this role, you will play a major role in shaping cohesive regulatory strategy across the programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy, while reporting directly to the Vice President of Regulatory Affairs.  The ideal professional is someone who possesses a flexible nature, and is a science minded thinker with well-developed communication skills.

Responsibilities:

  • Lead the development of regulatory strategy for multiple projects in development
  • Work with Global Regulatory Program Leads and Regional Representatives to ensure unified regulatory input into cross-functional development teams, clinical programs, and commercial strategy
  • Anticipate global regulatory changes and develops proactive strategy accordingly
  • Review and approve regulatory submission documents and Health Authority communications
  • Work to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations
  • Contribute to the continuous improvement of existing department processes and strategies, providing recommendations in their area of expertise

Knowledge and Skills:

  • Minimum of Bachelor’s degree in relevant scientific discipline, higher degree desirable
  • A minimum 12 years Pharma experience, of which at least 8 years is in Regulatory Affairs
  • Experience with developing and implementing competitive regulatory strategies
  • Experience with line and matrix management
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio
  • Experience dealing with broad range of stakeholders at all levels internal and external to the company
  • Demonstrated competence in employee management and development
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
  • Direct experience of leading regulatory authority meetings in different phases of drug development
  • Regulatory knowledge in a number of therapeutic areas

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