Associate Director, Global Regulatory Affairs - GI & Inflammation

Takeda • Boston, MA

93d • $153,600 - $241,340

About The Position

Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.

Requirements

• Bachelor’s Degree, scientific discipline strongly preferred.
• Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred.
• 6+ years of pharmaceutical industry experience, including 4+ years of regulatory experience.
• Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
• Solid working knowledge of drug development process and regulatory requirements.
• Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates strong skills with increasing independence in the area of regulatory strategy.

Responsibilities

• 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.
• Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs.
• Anticipates changes to lead adaptations to regulatory strategy.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success.
• Proactively anticipates risks and develops solutions to identified risks.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility.
• Direct point of contact with health authorities, leads and manages FDA meetings.
• Manages direct reports or junior staff as needed.
• Works with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations.
• Oversees vendor responsibility for regulatory activities and submissions related to projects within scope.
• Participates with influence in or leads departmental and cross-functional task-forces and initiatives.
• Leads regulatory reviewer in due diligence for licensing opportunities.
• Partners with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics.
• Monitors and anticipates trends that impact both the regulatory and access environments.

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.
• Up to 80 hours of sick time per calendar year.
• Accrual of up to 120 hours of paid vacation for new hires.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees