This position is responsible for directing global regulatory strategies for product development and approval and commercial support. Responsible for regulatory documents, submissions, and compliance issues. Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory guidance for various corporate wide teams/committees.

• Develop the global regulatory strategy
• Develop innovative life cycle management plans to achieve business objectives.
• Serve as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
• Review all external materials for regulatory compliance.
• Represent Regulatory Affairs on cross-functional project teams.
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the internal management teams as well as the executive management team.
• Create an environment conducive to a global view as part of the whole regulatory team.
• Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
• Will manage direct reports and have budget responsibility.

REQUIREMENTS

• Doctoral degree in the sciences, Pharmacy or Regulatory Science preferred.
• 15+ years pharmaceutical/biotechnology industry experience
• Minimum of 10-15 years in Regulatory Affairs.
• Global Regulatory Affairs experience required.
• Regulatory “Strategy” experience required.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
• Comprehensive knowledge of GCPs and GLPs.
• Ability to lead and influence project teams, committees, etc. to attain group goals.
• Demonstrated leadership and communication skills.
• Ability to represent the department in project teams, committees and external meetings.