Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Sciences

3 days ago


Cambridge, Massachusetts, United States Takeda Pharmaceutical Full time
Job Description

Takeda Pharmaceutical is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for our combination products, with a focus on Material Sciences.

Key Responsibilities:

  • Develop and implement regulatory strategies for combination products, ensuring compliance with relevant guidelines and regulations.
  • Collaborate with cross-functional teams to ensure effective implementation of regulatory strategies.
  • Provide expert guidance on Material Sciences and regulatory requirements to product teams.
  • Develop and maintain relationships with key stakeholders, including regulatory authorities and industry partners.
  • Stay up-to-date with emerging trends and developments in regulatory affairs and apply this knowledge to drive business growth.

Requirements:

  • 10+ years of experience in regulatory affairs, with a focus on combination products and Material Sciences.
  • Proven track record of developing and implementing successful regulatory strategies.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Strong knowledge of regulatory guidelines and regulations, including those related to combination products and Material Sciences.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.

What We Offer:

  • A competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • The chance to work on cutting-edge projects and contribute to the success of a leading pharmaceutical company.

How to Apply:

If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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