Director, Global Regulatory Affairs

THE POSITION:

• Gain complete understanding of product and transform that knowledge into regulatory strategy.
• Implement the strategy, engaging regulatory authorities and authoring submissions.
• Become an embedded member of the client’s organization, influencing the regulatory environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Deliver strategic regulatory considerations and paths to market to clients.
• Transform regulatory strategy into executable project plans.
• Serve as a trusted liaison with health authorities.

EXPECTATIONS OF THE JOB:

• Partner with clients to achieve business objectives and recommend regulatory strategies.
• Cross functional collaboration to ensure objectives and milestones are met.
• Consultative services and selling to clients.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum of 10 years of experience in Regulatory Affairs or Regulatory Consulting.
• Proven experience providing strategic regulatory advice to clients.
• Strong project management, communication, and interpersonal skills.