Job Title: Director, Global Regulatory Lead, GI & Inflammation
Location: Boston, Massachusetts
Job Level: Senior
Travel: Minimal (if any)
Job ID: R0145516
Date Posted: 02/25/2025
Job Description:
Objective / Purpose:
Defines, develops, and leads global strategies to maximize regulatory success for complex and/or multiple projects.
Provides strategic and tactical advice to teams to achieve timely development and maintenance of programs, ensuring compliance with regulatory requirements.
Serves as a leader in both the department and within R&D, contributing to cross-functional initiatives and influencing the field.
Provides leadership and development for direct reports, including those serving as global regulatory leads.
Accountabilities:
Leads Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, ensuring global regulatory strategy execution.
Ensures global regulatory strategies are implemented and maintained in line with regulatory and business changes.
Communicates with key stakeholders to inform them of developments impacting regulatory success.
Proactively anticipates risks and develops solutions with team and management.
Responsible for US FDA submissions and approvals for assigned projects or overseeing direct reports.
Manages relationships with health authorities and FDA meetings.
Oversees vendor responsibility for regulatory activities and submissions.
Participates in departmental and cross-functional task forces.
Leads regulatory reviewer in due diligence for licensing opportunities.
Partners with global market access colleagues on regulatory/health agency/HTA bodies.
Education & Competencies:
Bachelor’s degree in scientific discipline (advanced degree preferred).
8+ years in pharmaceutical industry with 6 years in regulatory experience (or 4+ years combined regulatory/related experience).
Experience in reviewing, authoring, or managing regulatory submissions.
Strong knowledge of FDA, EU, Canada, ROW, and post-marketing regulatory requirements.
Strong communication, negotiation, and problem-solving skills.
Ability to work effectively with global teams.
Compensation:
U.S. Base Salary Range: $169,400.00 - $266,200.00
Employees may be eligible for short-term/long-term incentives, benefits, and paid time off.
EEO Statement:
Takeda is committed to creating a diverse workforce and providing equal employment opportunities.
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