Senior Manager, US Medical Ad/Promo Regulatory Review

2 weeks ago


Lexington, Massachusetts, United States Takeda Full time
About the Role

Takeda is seeking a highly skilled Senior Manager, US Medical Ad/Promo Regulatory Review to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with FDA regulations and guidelines for the promotion of prescription drug and biologic products.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and implement regulatory strategies for promotional materials
  • Review and assess proposed promotional items to ensure compliance with regulatory requirements
  • Provide regulatory guidance and support to commercial teams
  • Develop and maintain relationships with regulatory agencies and industry partners
  • Stay up-to-date with changes in regulatory requirements and guidelines
Requirements
  • Bachelor's degree in life science or equivalent
  • Minimum 4 years' experience in drug, biologic or device Regulatory Affairs or related field
  • Strong knowledge of FDA regulations and guidelines
  • Excellent communication and interpersonal skills
  • Ability to work in a fast-paced environment
What We Offer
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance


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