Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factor Expert

5 days ago


Boston, United States Takeda Pharmaceutical Full time
Job Description

Takeda is seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team. As a key member of our CMC, Device and Combination Products team, you will be responsible for leading the development and implementation of innovative regulatory strategies, particularly in the area of Human Factors.

Key Responsibilities:

  • Develop and implement regulatory strategies for CMC, Device and Combination Products, with a focus on Human Factors.
  • Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations, with emphasis on Human Factors.
  • Establish mechanisms to communicate regulatory requirements to stakeholders and drive proactive implementation.
  • Influence global regulatory policies and guidance documents, and act as an advisor to senior management on Human Factors.
  • Collaborate with Takeda teams and leadership to ensure success in meeting goals and objectives.

Requirements:

  • BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline, Advanced Degree Preferred.
  • 10+ years of experience in a device and/or combination product role in pharmaceuticals and/or medical devices industry, including experience in regulatory CMC.
  • Experience working on cross-functional teams, leading and influencing on regulatory positions, to set programs on course for regulatory success.
  • Proven expertise and experience in the area of Human Factors and allied fields for drug-device combinations.
  • Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities, including expertise with proposing science-based, data-driven regulatory positions and conducting negotiations with regulators.

What We Offer:

  • Competitive salary range: $205,100.00 - $322,300.00.
  • Short-term and long-term incentives.
  • Medical, dental, vision insurance.
  • 401(k) plan and company match.
  • Short-term and long-term disability coverage.
  • Basic life insurance.
  • Tuition reimbursement program.
  • Paid volunteer time off.
  • Company holidays.
  • Well-being benefits.

About Takeda:

Takeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.



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