Director Global Regulatory Lead

Title: Director Global Regulatory Lead

A leading pharmaceutical company is growing their team with a Director Global Regulatory Lead to develop and lead global 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.
• 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 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.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Lead regulatory reviewer in due diligence for licensing opportunities.
• Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

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