Immunology Head, Regulatory Affairs
Full-time
AbbVie
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
Joining AbbVie means you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada.
When choosing your career path, choose to be remarkable.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, vision care, virology, women’s health , and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
Position Summary
The Immunology Head, Regulatory Affairs leads the Canadian regulatory strategy for AbbVie’s Immunology portfolio, including marketed products, lifecycle management, and pipeline assets. This role provides direction, management, and oversight of regulatory activities in support of business objectives, while ensuring compliance with Health Canada regulations, policies, and guidance. The role partners closely with global and local cross-functional stakeholders to enable timely submissions, approvals, and patient access.
Key Responsibilities
- Lead Canadian regulatory strategy and execution for the [therapeutic area / business area]
- Oversee submission, approval, and post-approval activities for clinical trial applications, new and supplemental drug submissions, and related product lifecycle changes
- Lead and support pre-submission interactions with Health Canada, including preparation of materials and strategic meeting support
- Identify and manage regulatory risks to support timely submissions and approvals
- Provide strategic regulatory leadership for development, launch, and post-launch activities
- Partner with local and global Regulatory Affairs, Commercial, Market Access, Medical Affairs, Pharmacovigilance, and Research & Development teams to define submission strategies and support portfolio priorities
- Review supporting documentation for compliance with applicable Health Canada legislation, regulations, policies, and guidance
- Monitor changes to the Canadian regulatory environment and provide comments to draft guidance and external consultations, influencing Canadian regulatory environment and landscape.
- Provide regulatory input to brand teams, early pipeline planning, launch readiness, and business development activities
- Support team effectiveness through coaching, development, and operational excellence
- Develop and oversee departmental budgets, and routinely monitor Regulatory Affairs expenses to ensure operations remain within PLAN budget
- Represent AbbVie on external trade association and related working groups, as applicable
Qualifications
Qualifications
- Bachelor’s degree in a scientific or related discipline required; advanced degree preferred
- Minimum of 10 years of leadership with supervisory role experience in the pharmaceutical or life sciences industry
- Proven experience leading regulatory strategy and execution for development and marketed products
- Strong knowledge of Health Canada regulations, policies, and submission requirements
- Demonstrated success working in a matrixed, cross-functional environment
- Strong leadership, communication, negotiation, and project management skills
- Experience with pharmaceuticals, biologics, medical devices, or other regulated products as applicable to the role
Core Competencies
- Strategic thinking and sound judgment
- Collaboration and influence in a matrix environment
- Accountability for delivery and operational excellence
- Strong problem-solving and risk management skills
- Coaching and talent development
- Clear communication and stakeholder management
AbbVie aims to offer a French-speaking workplace in Quebec and has made efforts to limit English requirements. However, advanced English skills are essential for this role because the position involves working with English-speaking employees, clients, and regions outside Quebec.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Vacancy posted 6 hours ago
Similar jobs that could be interesting for youBased on the Immunology Head, Regulatory Affairs in Montréal, QC vacancy
- ...vie des gens dans divers secteurs thérapeutiques clés, dont l’immunologie, l’oncologie, les neurosciences et les soins oculaires, de même... ...Allergan Esthétique. Sommaire du poste Le Gestionnaire en chef, Affaires réglementaires, Immunologie dirige la stratégie réglementaire...SuggestedDaily paidFull time
- ...Line Manager, Regulatory Affairs, Canada remote, This role combines people leadership and operational delivery, actively contributing to the execution of clinical trial regulatory activities. As a Line Manager & Regulatory Affairs Specialist, the employee will be responsible...SuggestedPermanent employmentFull timeFor subcontractorDirect hireWork at officeLocal areaRemote workWork from homeFlexible hours
- ...opportunity to work in a modern, inspiring environment. Job Description Reporting to the Senior Director, Legal and Regulatory Affairs, the Senior Legal Counsel will serve as a strategic partner to the various business units in a complex, dynamic, and highly regulated...SuggestedFull time
- ...orientations réglementaires en langage d’affaires clair. Compétences avancées avec Excel... ...abroad, are evolving at record speed. As a Regulatory Analyst on Targray’s Environmental... ...position requires 100% presence at Targray Head Office, Monday to Friday. Responsibilities...SuggestedFull timeInternshipWork at officeMonday to friday
$61 per hour
...Alphanumeric is hiring a Global Regulatory Affairs Manager CMC (Pharmaceuticals) to work remotely in Quebec or Ontario for one of the biggest Pharmaceutical companies in the world, based in Montreal, Quebec. Preference for candidates near Montreal due to the proximity...SuggestedRemote jobContract workFor contractorsMonday to friday- ...governance, and continuous disclosure. He or she plays a strategic role with senior management and the Board of Directors regarding regulatory obligations, governance best practices, and the organization’s corporate operations. The incumbent also contributes to the smooth...Full time
- ...future, and take ownership of your career with support at every stage. Join a firm where your career can make a difference. Our regulatory compliance practice helps organizations identify, manage and mitigate regulatory compliance risk exposures. We support highly regulated...Full timeInternship
$73.6k - $96.6k per year
...carrières inspirantes et des histoires qui laissent leur empreinte. Les essentiels du poste : Dans le rôle de spécialiste, affaires réglementaires, basé à Montréal, Québec, vous ferez partie de l’équipe Affaires juridiques et gouvernementales – Amériques. Vous travaillerez...ApprenticeshipWork at officeFlexible hoursDay shift$129.93k - $173.24k per year
...: Monday, June 22, 2026. We are seeking a Director, External Affairs to build and lead a high-performing, integrated external affairs... ...institutions , with an understanding of the reputational, regulatory, and public accountability considerations associated with deploying...Permanent employmentInternshipWork at office3 days per week$35 per hour
Overview Languages French Education ~ No degree, certificate or diploma Experience 1 year to less than 2 years On site Work must be completed at the physical location. There is no option to work remotely. Responsibilities Tasks Hire and...RemplacementFull timeContract workRemote work- Analyste d'affaires Date: 15 juin 2026 Lieu: Montreal, Québec, CA, H3B 2E3 Québec, Québec, CA, G1W 0E8 Toronto, CA, M5J 2M4 Type d’emploi: Hybride Vous avez une place chez nous si : ~Vous possédez au moins cinq...Full timeSummer workWork at officeRemote work
- Hire and train or arrange for training of cleaning staff Supervise and co-ordinate activities of workers Inspect sites or facilities to ensure safety and cleanliness standards Prepare budget and cost estimates Recommend or arrange for additional services required...RemplacementFull time
- Analyste d'affaires Description de poste CGI est à la recherche d’un(e) Analyste d’affaires bilingue possédant plus de 5 ans d’expérience en systèmes d’investissement financier, intelligence d’affaires et analyse de données. Le candidat idéal saura traduire les besoins...
- ...scale. As part of this evolution, the firm is building a best-in-class global treasury function from the ground up. This newly created Head of Treasury role represents a rare opportunity to design, build, and lead a strategic function at the heart of a sophisticated, multi-...Long term contractPermanent employment
- ...commentaires et avançons comme une seule équipe, car les grands résultats naissent d'une grande collaboration. About the Role As Head of Sales, you will own and drive Claio AI's commercial growth across Canada. You will be the primary architect of our go-to-market...Contract workApprenticeship
$43.89 per hour
On behalf of a prominent public sector organization dedicated to serving the community, Randstad Digital is seeking a seasoned Agile Business Analyst. In this role, you will act as the strategic bridge between operational ambitions and technological execution. You will analyze...Long term contractContract workTemporary workWork at officeFlexible hours2 days per week$43.89 per hour
...'envergure du secteur public reconnue pour son rôle essentiel auprès de la collectivité, Randstad Digital recherche un(e) Analyste d'affaires agile chevronné(e). En tant que pilier de la transformation, votre rôle consistera à analyser l'écosystème organisationnel, à identifier...Contract workTemporary workSummer workWork at officeRemote workFlexible hours2 days per week- ...DÉVELOPPEMENT DES AFFAIRESVous êtes passionné par le développement des affaires et vous recherchez une opportunité stimulante où vous pourrez... ...customized solutions to our clients?Working at Vision Group’s head office means working for one of North America’s leading vision correction...Permanent employmentFull timeTemporary workSummer workWork at officeRemote workFlexible hours
$90k - $110k per year
...Bonjour, Je suis Robin, conseiller en recrutement et développement des affaires au sein de FED IT, cabinet de recrutement spécialisé sur les métiers TI. J'interviens sur deux types de recrutement : temporaires et permanents. Tous nos conseillers en recrutements sont...Permanent employmentFull timeTemporary workRemote work- ...le bien-être de ses employés, l’équipe Bell est faite pour vous. L’équipe Bell Mobilité propose aux consommateurs et aux clients d’affaires les meilleurs et plus récents appareils mobiles, services sans fil et solutions Internet des objets, ainsi que les vitesses, la...Permanent employmentFull timeWork at officeFlexible hours
- ...C'est simple ; nous le faisons bien. Nous visons l'excellence. Description du poste Relevant du Spécialiste performance d’affaires, l’Analyste performance d’affaires joue un rôle clé dans l’amélioration de l’efficacité opérationnelle et de la performance des coûts...Full timeWorldwide
- ...Description de poste : Sous la responsabilité du directeur national des affaires de Syneos Health, le gestionnaire régional des affaires est chargé de définir une orientation stratégique et tactique alignée sur la stratégie globale de la marque pour l’équipe de vente sur...ApprenticeshipLocal areaFlexible hours
$105.3k - $122.85k per year
...a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all. Prof Vet Affairs Consultant - 8 Month Contract The Professional Vet Affairs Consultant plays an integral role in positioning Hill’s in the profession...Contract workWork at officeLocal areaRemote workRelocationFlexible hoursNight shift- ...le cadre de sa croissance et de la poursuite de sa mission, notre client est à la recherche d’un(e) Responsable du développement des affaires qui contribuera au rayonnement de l’organisation, au développement de partenariats stratégiques et à l’identification de nouvelles...Permanent employmentFull timeRemote work
brh réseau d’experts
Montréal, QC4 days ago - ...TEHORA est présentement à la recherche d' un(e) analyste d'affaires senior ayant d'excellentes aptitudes professionnelles, d'excellentes capacités d'analyse et qui souhaite mettre à profit ses compétences au sein d'une équipe polyvalente. La personne retenue contribuera à...Hourly payFull timeContract workApprenticeshipRemote workFlexible hours
- ...de métier » et leur intégration dans les activités quotidiennes. Développer et maintenir une vue transversale des fonctions d’affaires et des flux de traitements (chaines de valeurs), synthétiser et expliquer les interrelations entre les systèmes et les pratiques d’affaires...Work at office
- ...value of technology and build a more sustainable, more inclusive world. Job Description We are seeking an experienced AxiomSL Regulatory Reporting Developer with strong expertise in AXIOM ControllerView (version 9.8 and above) to support regulatory reporting...Permanent employmentFull timeLocal area
- Notre équipe recherche un Analyste d'affaires TI dynamique pour rejoindre un chef de file de l'industrie de l'assurance au Canada. Dans ce rôle, vous agirez comme le lien essentiel entre les besoins d'affaires complexes et l'exécution technique. Vous évoluerez dans un environnement...Contract workSummer workWork at officeRemote workFlexible hours2 days per week
- ...TEHORA est présentement à la recherche d'un(e) analyste d'affaires junior ayant de bonnes aptitudes d'analyse, une grande capacité d'apprentissage et qui souhaite mettre à profit ses compétences au sein d'une équipe polyvalente. La personne retenue soutiendra les activités...Hourly payFull timeContract workRemote workFlexible hours
- ...responsabilités sont En tant que Représentant.e du développement des affaires, vous jouerez un rôle essentiel dans la croissance de LIDD. Votre... ...; ~ Excellent written and spoken communication skills; ~ Willing to work in person form our head office in the Old Port....Work at officeDay shift
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Immunology Head, Regulatory Affairs. Be the first to apply!
Related searches
- regulatory compliance director Montréal, QC
- regulatory manager Montréal, QC
- quality compliance manager Montréal, QC
- directeur juridique Montréal, QC
- safety compliance manager Montréal, QC
- compliance manager Montréal, QC
- regulatory affairs project manager Montréal, QC
- customs compliance manager Montréal, QC
- regulatory Montréal, QC
- regulatory counsel Montréal, QC