Remote: Associate Director, Global Regulatory Affairs (A&P)

Takeda Pharmaceutical; Zürich; Remote; CHF 159,000 - 219,000; Full time

Job summary

Takeda in Zurich seeks an Associate Director, Global Regulatory Affairs Advertising and Promotion Review Lead to guide regulatory strategy for prescription medicines across US and international codes, guidance and industry standards.

You will lead global CMRP, chair meetings, provide regulatory guidance through development, review, and implementation of medical and commercial materials, and partner across clinical development, marketing and safety to ensure patient safety and compliant campaigns.

Qualifications

• Bachelor's degree preferred, BA accepted.
• 8+ years in pharmaceutical industry with 6+ years regulatory experience or 5+ regulatory/related experience combined.
• Ability to understand ABPI, EFPIA and other international codes for advertising and promotion of prescription medicines.
• Experience in promotion development and review processes for prescription medicines.
• Strong interpersonal, analytical thinking and strategic communication skills.
• Proven negotiation, cross-functional leadership and conflict resolution abilities.
• Ability to work independently, take initiative and meet deadlines.

Responsibilities

• Act as SME for assigned products focusing on advertising and promotion regulatory affairs.
• Provide regulatory guidance during development, review, approval and implementation of materials.
• Lead as product/project business lead for global CMRP at Takeda.
• Chair CMRP meetings, coordinate comments, and manage escalations when alignment is needed.
• Partner across clinical development through marketing maintenance in the product lifecycle.
• Maintain SME status on EFPIA, IFPMA, and FDA codes/guidance for promotional platforms.
• Drive strategic regulatory input to ensure patient safety and compliance.

Job description

Takeda in Zurich seeks an Associate Director, Global Regulatory Affairs Advertising and Promotion Review Lead to guide regulatory strategy for prescription medicines across US and international codes, guidance and industry standards.

You will lead global CMRP, chair meetings, provide regulatory guidance through development, review, and implementation of medical and commercial materials, and partner across clinical development, marketing and safety to ensure patient safety and compliant campaigns.