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Global Regulatory Affairs Director for Marketed Products

3 weeks ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Lead Global Regulatory Strategy

About the Role:

Takeda Pharmaceutical is a pioneering R&D organization driving innovation in transformative therapies for patients worldwide.

We are seeking an Associate Director, Global Regulatory Affairs Marketed Products to spearhead global regulatory success and maximize program objectives for complex projects.

Your Key Responsibilities:
  • Direct the Global Regulatory Team (GRT) and sub-working groups, ensuring effective collaboration with project teams.
  • Develop and implement strategic plans to ensure global regulatory compliance, aligning with cross-functional teams.
  • Maintain open communication with project team colleagues, management, and stakeholders regarding regulatory developments.

This role will oversee increasingly complex or multiple projects, leading the GRT and applicable sub-working groups, and representing GRT at project team meetings. You will define strategies and provide tactical guidance to teams, collaborating cross-functionally to update and execute the global regulatory strategy.

Requirements:
  • Bachelor's Degree, preferred. Bachelor's accepted.
  • Minimum 8 years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 5+ years of regulatory and/or related experience.
  • Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
About Us:

Takeda Pharmaceutical is transforming patient care through innovative specialty pharmaceuticals and best-in-class patient support programs. We foster a culture of diversity, innovation, and excellence, empowering our teams to deliver Better Health and a Brighter Future to people worldwide.

Compensation and Benefits:

The estimated annual salary for this position is $149,100 - $234,300. U.S.-based employees may be eligible for short-term and long-term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits.

EEO Statement:

Takeda Pharmaceutical is committed to creating a diverse workforce and providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or other protected characteristics.