City : Toronto

Category : Autre

Industry : Healthcare

Employer : GSK

Nom du site: Mississauga Milverton Drive, Mexico City Torre Mitikah
Date de publication: Mar 16 2026

Are you energized by a highly impactful regulatory affairs role that allows you to shape and accelerate regulatory effectiveness across the organization?  If so, this Regulatory Affairs Operations Manager role could be an ideal opportunity to explore. The Regulatory Submission Lead is responsible for independently supporting regulatory submission activities for assigned deliverables, ensuring compliance with health authority regulations and GSK policies. The role authors, reviews, compiles and delivers dossiers using Veeva Vault, collaborates with Submission teams, Local Operating Company contacts and Global Regulatory/Functional teams, and provides mentoring and training to new team members.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• Independently deliver assigned submissions according to agreed dossier strategy, collaborating with functional teams (CMC, Clinical, Nonclinical, etc.) and LOC contacts; ensure adherence to timelines in assigned markets.

• Oversee multiple simultaneous project assignments (e.g., CMC and therapeutic Variations, PBRER, Renewals, Site Registrations/Site Renewals, complex Tenders).

• Manage complex regulatory registration requirements from agencies, manufacturing sites or third-party providers, including providing site support to meet regulatory expectations.

• Prepare, coordinate and ensure timely delivery of documents requested by health authorities, legalization providers, manufacturing sites or third parties.

• Engage cross-functionally and with senior process-development teams to provide regulatory advice, interpret guidelines, conduct research and resolve complex issues.

• Provide training, consultation and tailored solutions within and beyond the department; possess comprehensive knowledge of GSK processes and workflows.

• Maintain alignment with regulatory requirements, legislation and guidelines for EU, US and ROW markets; perform data assessments to confirm dossier fitness-for-purpose.

• Conduct scenario planning for multiple regulatory strategies and recommend delivery approaches to support accelerated timelines; proactively escalate business-impacting issues and propose solutions.

• Act as a peer reviewer for deliverables and recommend improvements to regulatory processes, policies and systems to drive efficiency and innovation.

• Engage with regulatory agencies to address and resolve issues within area of responsibility.

• Demonstrate thorough understanding of regulations, guidelines, procedures and policies related to registration and manufacturing to expedite submission, review and approval of global applications.

• Communicate effectively with internal and external stakeholders on project- and policy-related matters with minimal managerial supervision.

• This role follows GSK’s "Performance with Choice" hybrid working model, combining regular on-site collaboration for stakeholder‑facing and team activities with flexible remote work for focused individual tasks and deliverables.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree or higher in biological or healthcare science

• 5 years of experience with strong understanding of the industry, drug development and R&D processes.

• In-depth knowledge of regulations, guidelines and policies for pharmaceutical and vaccine registration and manufacturing.

• Proficient in Veeva Vault for submission deliverables.

• Excellent organizational, communication and interpersonal skills; able to deliver high-quality results under tight deadlines.

• Skilled at interpreting global regulatory requirements and providing expert guidance informed by recent GSK experience.

• Adaptable and proactive in managing workload, priorities and timelines within a matrix environment.

• Proven ability to manage multiple projects concurrently and build strong internal stakeholder relationships.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master’s degree or MBA

• Experience working in a matrixed environment

• Demonstrated ability to engage and influence senior stakeholders.

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.

• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

• Continuously looking for opportunities to learn, build skills and share learning.

• Sustaining energy and well-being.

• Building strong relationships and collaboration, honest and open conversations.

• Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

#LI-Hybrid

In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD82,000 to CAD132,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our recruitment process.Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process.

Pourquoi GSK?
Allier science, technologie et talent pour vaincre ensemble la maladie.

GSK est une entreprise biopharmaceutique mondiale dont la mission est de réunir la science, la technologie et le talent pour prendre ensemble de l'avance sur les maladies. Nous visons à avoir un impact positif sur la santé de 2,5 milliards de personnes d'ici la fin de la décennie, en tant qu'entreprise prospère et en croissance où les gens peuvent s'épanouir. Nous prenons de l'avance sur les maladies en les prévenant et en les traitant grâce à l'innovation dans les médicaments spécialisés et les vaccins. Nous nous concentrons sur quatre domaines thérapeutiques : les maladies respiratoires, l'immunologie et l'inflammation; l'oncologie; le VIH; les maladies infectieuses – pour avoir un impact à grande échelle sur la santé.

Les gens et les patients partout dans le monde comptent sur les médicaments et les vaccins que nous produisons; c'est pourquoi nous nous engageons à créer un environnement où nos employés peuvent s'épanouir et se concentrer sur ce qui compte le plus. Notre culture, qui repose sur l'ambition pour les patients, la responsabilité de la portée et le fait de faire ce qui est juste, constitue la base de la manière dont nous tenons nos engagements ensemble pour les patients, les actionnaires et nos employés.

GSK est un employeur offrant l'égalité des chances. Cela garantit que tous les candidats qualifiés recevront une considération égale pour l'emploi sans distinction de race, de couleur, de religion, de sexe (y compris la grossesse, l'identité de genre et l'orientation sexuelle), de statut parental, d'origine nationale, d'âge, de handicap, d'informations génétiques (y compris les antécédents médicaux familiaux), de service militaire ou de toute autre base interdite par la loi fédérale, étatique ou locale. GSK s'engage à accueillir les personnes handicapées. Si vous avez besoin d'un aménagement à n'importe quelle étape du processus de candidature ou si vous souhaitez plus d'informations sur nos politiques d'aménagement, veuillez nous contacter à canada-recruitment@gsk.com. Veuillez ne pas envoyer de CV à cette adresse e-mail et postuler plutôt via le processus de candidature en ligne de cette annonce.

Avis important destiné aux services/agences de placement

GSK n’accepte pas les propositions des services/agences de placement en vue de pourvoir les postes affichés dans le présent site. Ces services/agences doivent s’adresser au service d’approvisionnement/des ressources humaines de GSK pour obtenir une autorisation écrite avant de lui proposer des candidats. Cette autorisation est une condition préalable à toute entente (orale ou écrite) entre le service/l’agence de placement et GSK. Sans cette autorisation écrite, toute mesure de la part du service/de l’agence de placement doit être considérée comme avoir été appliquée sans le consentement ni l’entente contractuelle de GSK. Par conséquent, GSK ne peut pas être tenue responsable des honoraires attribuables à de telles mesures ni à quelque recommandation que ce soit de la part du service/de l’agence de placement en ce qui concerne sa proposition de candidature en vue de pouvoir un poste annoncé dans le présent site.