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Vp, Head Eucan Regulatory Strategy

10+ years
Not Disclosed
10 April 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

VP, Head EUCAN Regulatory Strategy
Location: Zurich, Canton of Zurich
Job Type: Full Time
Job Level: Senior
Travel: Minimal (20% of time)

Job Description:

Takeda is seeking a VP, Head of EUCAN Regulatory Strategy to lead the regulatory strategy for Takeda products within the EUCAN region (Europe + Canada). This position will be a key member of the International RA leadership team, responsible for setting the strategic direction, overseeing development plans, and providing regulatory guidance across the therapeutic areas (TAs) in the EUCAN region.

Key Responsibilities:

  • Regulatory Strategy: Lead the development of regulatory strategies aligned with the global RA strategy to achieve optimal development and lifecycle management of Takeda's products in the EUCAN region.

  • Team Leadership: Lead the EUCAN Regulatory Affairs team, ensuring regulatory activities align with commercial priorities, supporting R&D, and facilitating strong engagement with Health Authorities.

  • Collaboration: Partner with internal stakeholders, including GRA TAUs, EUCAN commercial, and CMC teams, to drive effective regulatory solutions and facilitate the successful launch of products.

  • Regulatory Intelligence: Research and anticipate emerging regulatory trends, preparing Takeda to adapt and comply proactively.

  • Regulatory Process Management: Ensure timely filing and approval of new products and the maintenance of existing products, offering regulatory expertise and guidance across regions.

  • Cross-functional Leadership: Engage in global regulatory development strategies and provide regulatory input on key business decisions.

Qualifications:

  • Education: Master’s or advanced degree in a relevant scientific field (MD, PhD, PharmD).

  • Experience: Minimum 18 years of pharmaceutical industry experience, with at least 10 years in Regulatory Affairs, preferably with experience in drug development and commercial processes.

  • Regional Experience: Experience in the EUCAN region required.

  • Skills: Strong leadership abilities, excellent communication and project management skills, and deep regulatory knowledge. Must have experience in biologics, small molecules, and CTA/MAA processes.

What Takeda Offers:

  • Leadership Role: Opportunity to lead and shape regulatory strategy across multiple regions and therapeutic areas.

  • Global Influence: Influence regulatory strategies at a global level and collaborate across regions and departments.

  • Career Growth: The chance to advance your career within a top-tier global pharmaceutical company.