Senior Director, Global Regulatory Affairs Leader in Pharmaceutical Development

3 days ago


Boston, Massachusetts, United States Takeda Pharmaceutical Full time

Takeda Pharmaceutical is a patient-focused company that transforms patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs.

We are seeking a highly experienced Senior Director to lead our GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development, commercialization, and post-approval LCM stages.

This role involves establishing collaboration with Global CMC teams and leadership through networks and enabling CMC regulatory team's success in meeting goals/objectives. The successful candidate will influence changing regulations and guidance documents, interface with outside regulatory agencies and trade associations, and act as an advisor/liaison to senior management to plan, evaluate, and recommend implementation strategy.

Key Responsibilities:

  • Lead the Early Development Pharmaceuticals GRA CMC regulatory team
  • Combine knowledge of scientific, regulatory, and business issues to ensure high-quality regulatory filings
  • Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations
  • Globally influence and be considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry
  • Responsible for demonstrating Takeda leadership behaviors

Requirements:

  • Advanced Degree or PhD in Life Sciences, Pharmacy, or related discipline
  • Minimum 15 years of experience within regulatory agencies or the Pharmaceutical Industry including significant leadership experience in Regulatory Sciences
  • Significant understanding and track record in dealing with international regulations and policies setting processes of major regulatory agencies
  • Actively engaged in major industry associations and joint regulator/industry initiatives
  • Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills

What We Offer:

  • A competitive salary range of $205,100 - $322,300 per year
  • Eligibility for short-term and long-term incentives
  • A comprehensive benefits package, including medical, dental, vision insurance, 401(k) plan, company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits

Takeda is proud to offer a diverse and inclusive work environment where everyone has the opportunity to grow and succeed. If you're passionate about making a difference in patients' lives and have the skills and experience to excel in this role, we encourage you to apply.



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