Director, Global Regulatory Lead, GI & Inflammation

Directs global regulatory strategies to maximize regulatory success for complex projects. Provides strategic advice to teams and leads cross-functional initiatives. Develops and leads global regulatory teams and represents them at project team meetings. Ensures global regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs.

Requirements

• Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives
• Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs
• Leads cross-functional initiatives and influences the field as applicable
• Develops and leads global regulatory teams and represents them at project team meetings
• Ensures global regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs
• Accountable for building global regulatory strategies as defined within the GRT
• Oversees vendor responsibility for regulatory activities and submissions related to projects within scope

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits