Manager, Regulatory Affairs

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Job Description

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

• Extensive working knowledge and application of the Canada Food and Drugs Act and Regulations; and key policies, guidance and codes (i.e. Health Canada, ICH, PAAB, ASC, and IMC). Familiarity with policies and guidance of the EU EMA and US FDA.

• Experience in filing new drug submissions and negotiating Health Canada authorizations from initial development and throughout entire product life cycle; and regulatory review of drug advertising for pre-clearance by PAAB and ASC.

• Understanding of scientific principles, quality management systems, and regulatory life-cycle requirements for the development, approval, and ongoing maintenance of drugs in compliance with Health Canada requirements.

• Asset: Bilingual fluency in French (written and spoken).

Business Leadership Skills

• Ability to build and maintain strong, respectful relationships with external stakeholders and Takeda teams—grounded in credibility, discretion, and trust.

• Understanding of marketing, reimbursement/pricing, clinical development, and international regulatory functions, and how they relate to Canadian strategy—paired with the ability to align teams through influence.

• Ability to solve problems and propose alternative solutions before escalating issues—using judgment, accountability, and stakeholder management.

• Strong negotiation and conflict resolution skills to support positive regulatory outcomes with health authorities.

• Ability to help maintain commercial advantage by leveraging in-depth knowledge of therapeutic areas and key competitors and translating it into strategic choices.

Technological Leadership Skills

• Advanced data literacy and AI fluency (beyond using pre-approved tools; understanding limitations and risks) with human accountability for decisions and outputs.

• Change management and digital transformation leadership focused on adoption, governance, and behavior change.

• Advanced ethical and risk assessment skills (especially as AI-generated content becomes more prevalent).

• Regulatory technology (RegTech) implementation and oversight, including process ownership and control design.

• Cybersecurity and data privacy awareness in regulatory contexts, including human escalation and incident judgment.

• Continuous learning mindset to keep pace with evolving digital tools and regulatory landscapes.

• Asset: Deep expertise in AI/ML governance, digital workflow optimization, and regulatory technology integration; advanced training in digital ethics and bias mitigation; proactive upskilling in new regulatory technologies and digital collaboration platforms.

EDUCATION, LICENSES/CERTIFICATIONS, EXPERIENCE

• BS/BA University degree in Health Sciences

• 5 years’ experience in pharmaceutical industry

• Asset: Masters or Advanced Degree

TRAVEL & WORKPLACE REQUIREMENTS

• Hybrid work environment requiring specified time in office as per company policy

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required

• Requires approximately 5% travel

Takeda Canada encourages applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial accessibility legislation, please advise us if you need accommodation in order to participate in the recruitment process. Any information you provide relating to accommodation will be addressed confidentially.

Locations

Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Canada based employees may be eligible for a comprehensive range of benefits and incentives. Benefit eligibility varies by position and can include, amongst others:

• short-term and/or long-term incentives

• subsidies for fitness and internet

• medical, dental, and vision insurance

• basic life and accidental death and dismemberment (AD&D) insurance

• participation in the Registered Retirement Savings Plan (RRSP); company match into a Deferred Profit-Sharing Plan (DPSP) (if eligible)

• short-term and long-term disability coverage

• annual vacation entitlement; additional paid time off and company holidays

• a tuition reimbursement program

• a variety of well-being benefits

Les collaborateurs basés au Canada peuvent, selon leurs postes, bénéficier d’un ensemble complet d’avantages sociaux. L’éligibilité à ces avantages varie selon le poste, et peut inclure:

• des primes ou dispositifs d’intéressement à court et/ou long terme,

• des subventions pour les abonnements sportifs et abonnements internet

• une assurance santé incluant la prise en charge des frais médicaux, dentaires et optiques

• une assurance vie de base ainsi qu’un assurance en cas de décès ou de mutilation accidentels (AD&D)

• une participation au Régime enregistré d’épargne-retraite (REER) ; contribution équivalente de l’entreprise dans un régime de participation différée aux bénéfices (RPDB) (si admissible)

• une couverture en cas d’incapacité de travail temporaire ou prolongée

• un droit à congés payés annuels, avec jours de vacances, jours de récupération et jours fériés spécifiques à l’entreprise

• un programme de remboursement des frais de scolarité

• une variété d’avantages liés au bien-être

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