Senior Director Regulatory Affairs

Title: Senior Director Global Regulatory Lead

A leading pharmaceutical company is growing their team with a Senior Director Global Regulatory Lead to develop and lead lobal regulatory strategies for complex projects. This is an exciting chance to join a leading company in the industry to support high-level strategies across the entire drug development lifecycle.

Responsibilities:

• The Senior Director will be responsible for complex or highly complex or multiple projects. Lead the Global Regulatory Teams and applicable sub-working groups, such as the Label Working Group, and represents Global Reg teams at project team meetings.
• Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Senior Director will lead all submission types.
• Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs.
• Direct point of contact with health authorities, leads and manages FDA meetings.

Qualifications

• 10+ years of Regulatory Affairs experience in the pharmaceutical industry
• Bachelor's Degree, scientific discipline strongly preferred
• Advanced degree in a scientific discipline strongly preferred
• Strong working knowledge of drug development process and regulatory requirements
• US and Global perspective preferred