Associate Director, Global Regulatory Affairs – GI & Inflammation
Location: Boston, Massachusetts, USA (Hybrid)
Job Type: Full-Time | Senior-Level Regulatory Affairs
Job ID: R0146894
About Takeda
Takeda is a global biopharmaceutical leader committed to transforming patient lives through innovative therapies. Our Global Regulatory Affairs (GRA) team develops and executes strategic regulatory solutions across all stages of product development, ensuring compliance and enabling timely access to life-changing medicines worldwide.
At Takeda, we foster an environment of continuous learning, growth mindset, and career empowerment, providing our people with the resources to excel and lead in global healthcare innovation.
Role Overview
The Associate Director, Global Regulatory Affairs – GI & Inflammation will define and lead global regulatory strategies for complex or multiple projects. This role provides strategic and tactical guidance to cross-functional teams to ensure regulatory compliance, efficient submissions, and successful program outcomes.
You will serve as a key influencer across R&D, representing regulatory strategy at senior leadership and project team levels, while mentoring direct reports and regulatory leads to drive global compliance and operational excellence.
Key Responsibilities
Lead Global Regulatory Teams (GRTs) and relevant sub-working groups (e.g., Label Working Group), ensuring execution of global regulatory strategies.
Define and implement global regulatory strategies aligned with evolving regulations and business objectives.
Provide strategic and tactical advice to teams for timely, compliant submissions, including US FDA and other global health authorities.
Serve as primary liaison with health authorities, managing FDA meetings and regulatory communications.
Oversee direct reports and junior staff, guiding regulatory activities, submissions, and compliance efforts.
Collaborate with cross-functional teams and external vendors to ensure global regulatory submissions are delivered on time and meet local and international requirements.
Participate in departmental and cross-functional initiatives, licensing due diligence, and joint regulatory/HTA interactions.
Monitor trends affecting regulatory and market access environments, proactively adapting strategies.
Qualifications & Experience
Bachelor’s degree in a scientific discipline required; PharmD, PhD, or MD strongly preferred.
6+ years in the pharmaceutical industry, including 4+ years in regulatory affairs.
Proven experience in reviewing, authoring, or managing regulatory submissions (NDA, IND, BLA, etc.).
Strong knowledge of global regulatory frameworks, including FDA, EMA, Canada, ROW, and post-marketing requirements.
Demonstrated ability to interpret complex scientific data for regulatory strategy.
Excellent communication, presentation, negotiation, and project management skills.
Ability to lead global teams, provide mentorship, and influence cross-functional stakeholders.
Why Join Takeda
Global impact: Drive regulatory strategies for therapies that transform patient lives.
Career growth: Work in a collaborative environment fostering continuous learning and leadership development.
Competitive compensation: U.S. base salary range $153,600 – $241,340, with eligibility for incentives and comprehensive benefits.
Location: Boston, MA | Hybrid work policy
Application Deadline: Open
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