Associate Director, Global Regulatory Affairs
Company Overview
Global Regulatory Affairs (GRA) at Takeda develops and executes innovative regulatory strategies to deliver life-changing therapies to patients. GRA plays a strategic role in all stages of global product development across the Takeda Enterprise. We are committed to fostering a growth mindset and providing transformational opportunities for every team member.
Job ID: R0136180
Date Posted: 10/11/2024
Location: Boston, Massachusetts
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Job Description
Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA.
Key Responsibilities
Serve as the Global and US Regulatory Strategic Lead (GRL) for the immunology and inflammation therapeutic franchise on the global project team (GPT) for specific projects.
Provide global regulatory oversight and execute regulatory activities for late-stage development across multiple indications, device platforms, and cell line changes.
Manage interactions with health authorities, including preparation for meetings with the FDA (Type B, end of phase 2 meetings), EMA, BRDD (Canada), and PMDA (Japan).
Lead the development of global regulatory supplemental biologic application (sBLA) strategies and coordinate the global cross-functional submission working group.
Drive global submission strategy across various respiratory indications and collaborate with the global regulatory team to ensure successful pre-submission meetings and marketing application submissions.
Qualifications
Education: Master’s degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field.
Experience: Minimum of 7 years of relevant experience in regulatory affairs.
Proven experience in global regulatory oversight, particularly in immunology and inflammation.
Strong background in preparing for and leading health authority interactions.
Ability to travel domestically and internationally, up to 20%.
Compensation
Salary Range: $212,400.00 - $290,400.00 per year.
To apply, please visit jobs.takeda.com and search for Req # R0136180.
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