Director Regulatory Affairs

Title: Director Global Regulatory Affairs

A leading pharmaceutical company is growing their team with a Director Global Regulatory Lead to develop and lead global clinical 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 Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs 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.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The 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.
• Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local affiliates in compliance with local regulations and to maintain compliance for products.

Qualifications

• 8+ 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