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TATakeda Development Center Americas, Inc.

Associate Director, Global Regulatory Affairs, Advertising and Promotion(m/w/x)

Zürich
Full-timeWith Home OfficeSenior

Regulatory guidance for global advertising and promotion materials, leading CMRP reviews for assigned products at an R&D-driven biopharmaceutical company. 8+ years pharmaceutical industry experience, 6+ years regulatory experience, and ABPI/EFPIA advertising codes knowledge required. Global project leadership for regulatory review processes.

Requirements

  • BSc Degree or BA
  • 8+ years of pharmaceutical industry experience
  • 6 years of regulatory experience or 5+ years regulatory and/or related experience
  • Understanding of ABPI, EFPIA and international advertising codes
  • Experience in prescription medicine promotion development
  • Strong interpersonal skills
  • Ability to communicate clearly and concisely
  • Effective written and verbal communication skills
  • Proven negotiation and influencing skills
  • Cross-functional people management skills
  • Ability to work independently and meet deadlines
  • Previous experience in advertising and promotion role
  • Experience in regulatory affairs, particularly advertising and promotion
  • Strong leadership and conflict resolution skills
  • Strategic mindset for regulatory impacts assessment
  • Guiding teams through advertising and promotion processes

Tasks

  • Act as the Subject Matter Expert for assigned products and projects
  • Provide regulatory guidance during the development and review of medical and commercial materials
  • Serve as the Regulatory Advisor in the Medical, Legal, and Regulatory review process
  • Lead global CMRP as the product or project business lead
  • Chair CMRP meetings and facilitate communication among team members
  • Negotiate and resolve team disputes while maintaining focus on patient needs
  • Oversee escalation steps for alignment on new data or campaigns
  • Partner strategically from clinical trial development through product marketing
  • Provide expertise on EFPIA, IFPMA, and FDA codes and regulations
  • Ensure compliance and patient safety within the CMRP
  • Lead and motivate team members to achieve organizational goals
  • Identify and implement processes for reviewing promotional materials
  • Advocate for and implement positive change within the organization
  • Analyze complex issues and propose effective solutions
  • Communicate clearly and concisely in all interactions
  • Adapt to various personalities to foster goal achievement
  • Collaborate effectively in a cross-functional team environment
  • Create and deliver impactful presentations with focused recommendations

Work Experience

  • 8 years

Education

  • Bachelor's degree

Languages

  • EnglishBusiness Fluent
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