Manager, Regulatory Affairs

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PURPOSE

Lead regulatory projects across the product life cycle (development, authorization, and marketing) by shaping and owning Canadian regulatory strategies that protect patients, enable business outcomes, and uphold Takeda’s standards. Ensure full compliance for products developed and sold in Canada through expert professional judgment, clear accountability for decisions and sign‑off, and trusted, credibility‑based relationships with Health Canada and internal stakeholders.

This role depends on human interpretation of evolving requirements, values‑based decision‑making under uncertainty, and the ability to influence, negotiate, and resolve conflict to reach compliant, practical outcomes. The role is accountable for final recommendations, content/position approvals, and timely escalation when risk, ethics, or ambiguity requires senior alignment.

KEY ACCOUNTABILITIES

• Shape regulatory strategy with accountable judgment. Develop and recommend regulatory strategies for Canadian pipeline and marketed products that support business goals by interpreting incomplete information, weighing trade‑offs, and aligning diverse stakeholder priorities. Provide regulatory guidance through real‑time collaboration, coaching, and influence. Own regulatory risk assessments and mitigation plans, including decisions requiring escalation supported by a clear, executive‑ready rationale (e.g., data and IP protection, accelerated pathways, supply continuity).

• Lead Health Canada engagement through presence and credibility. Prepare and personally stand behind high‑quality briefing packages and submissions that are coherent, defensible, patient‑centered, and ethically sound. Lead interactions with Health Canada (meetings, calls, written responses) with professionalism, diplomacy, and constructive negotiation. Align cross‑functional teams to business goals while resolving disagreements, building consensus, and making final judgment calls in compliance with local regulations and Takeda policies and procedures.

• Convert external change into human‑led insight and action. Stay current on relevant regulations, products, competitors, therapeutic areas, and industry trends; interpret what matters and why. Monitor change through Health Canada publications (e.g., Gazette, What’s New), medical congresses, and industry/professional associations (e.g., IMC, BIOTECanada, CAPRA, RAPS), translating signals into recommendations that clarify what to do, when to do it, and the rationale.

• Model integrity and build sustainable compliance behavior. Reinforce a culture of compliance by following Takeda SOPs, policies, and best practices (e.g., Job‑Aids, TOOLS) and applying ethical judgment where guidance is unclear or conflicting. Develop internal policies and procedures (e.g., SOPs, TOOLS) by facilitating stakeholder input, addressing real‑world adoption barriers, and creating accountability mechanisms that sustain compliant behaviors over time.

• Lead projects by guiding people through ambiguity. Plan and manage tasks, timelines, and resources to deliver regulatory and commercial outcomes while adapting to shifting priorities. Communicate expectations clearly and early; use influence and negotiation to secure commitments, reconcile competing deadlines, and maintain trust during escalations or late‑breaking changes.

• Make nuanced, accountable decisions on promotion and labeling. Review promotional materials and labels to ensure compliance with regulatory and code requirements by applying human interpretation of intent, risk, and audience impact. Partner with stakeholders to shape compliant behavior, resolve disputes constructively, and make final decisions on acceptable claims and labeling positions when precedent is limited or judgment is required.

KEY COMPETENCIES

Occupational Knowledge

• Extensiv…