Regulatory Affairs Expert for Complex Projects

3 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time
Transform Patient Care with Takeda Pharmaceutical. We're seeking a highly skilled Associate Director, Global Regulatory Affairs Marketed Products to lead complex projects and ensure global regulatory compliance.

**Job Summary:**
This role is responsible for defining, developing, and leading global strategies to maximize regulatory success for complex projects. You will provide strategic and tactical advice to teams, ensuring timely and efficient development and maintenance of programs while maintaining compliance with applicable regulatory requirements.

About the Role:
As an Associate Director, you will be a leader within Takeda and external organizations, contributing to cross-functional initiatives and influencing the field as applicable. You will be responsible for increasingly complex or multiple projects, leading the Global Regulatory Team (GRT) and representing GRT at project team meetings.

The ideal candidate will have 8+ years of pharmaceutical industry experience, including 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience. A solid working knowledge of drug development processes and regulatory requirements is essential, with preferred experience in reviewing, authoring, or managing components of regulatory submissions.

**Key Responsibilities:**
  • Define and develop global strategies to maximize regulatory success for complex projects.
  • Provide strategic and tactical advice to teams, ensuring timely and efficient development and maintenance of programs.
  • Lead the Global Regulatory Team (GRT) and represent GRT at project team meetings.
  • Ensure global regulatory compliance and oversee direct reports or junior staff as needed.

What We Offer:
Takeda is a patient-focused company that inspires and empowers employees to grow through life-changing work. We offer stimulating careers, encourage innovation, and strive for excellence in everything we do. Our comprehensive benefits package includes medical, dental, vision insurance, a 401(k) plan, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits. U.S.-based employees are eligible to receive up to 80 hours of sick time and accrue up to 120 hours of paid vacation.

**Estimated Salary Range:** $149,100 - $234,300

We understand compensation is an important factor as you consider the next step in your career. For this position, we estimate the salary range based on qualifications, experience, specific skills, level of education attained, certifications or other professional licenses held, and location. The actual base salary offered may vary depending on these factors.

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