Job Description

Site Name:

Canada - Quebec - Quebec, Canada - Ontario - Mississauga, Montreal Queen Street

Posted Date:

May 20 2025

EN version to follow FR


Etes-vous passionne par la chimie, la fabrication et les controles (CMC) dans le domaine des affaires reglementaires ? Notre bureau de Quebec est a la recherche d'un gestionnaire enthousiaste a l'idee d'appliquer ses competences sur notre site de vaccination.

Objectif du

poste:

Vous serez responsable des activites reglementaires de CMC dans la phase avancee du developpement et/ou de la gestion du cycle de vie commercial des produits GSK.

Details

(

vos

responsabilites

):

Responsable des activites reglementaires mondiales de CMC pour les projets assignes et capable de repondre facilement aux evenements et aux priorites changeants. Responsable de l'elaboration de la strategie de CMC, avec le soutien de la direction, pour les documents de soumission de CMC afin de soutenir les activites de gestion du cycle de vie des produits commercialises conformement aux normes reglementaires et scientifiques applicables. Comprendre, interpreter et conseiller les equipes sur les reglementations, les directives, les procedures et les politiques relatives a la fabrication et au controle des produits medicinaux, afin d'accelerer la soumission, l'examen et l'approbation des demandes mondiales de CMC. S'assurer que tous les aspects reglementaires appropries de CMC pour la liberation du produit sont en place, afin d'assurer la continuite de l'approvisionnement du marche. Garantir que les informations soumises pour les soumissions de maintenance du cycle de vie repondent aux exigences regionales, ce qui permet une flexibilite maximale en matiere d'approvisionnement, de production et de qualite avec un minimum de questions imprevues. Travailler au sein d'equipes de projet matricielles interfonctionnelles, avec des collegues de la reglementation, du developpement, de la qualite et de la fabrication, assurant une interaction et un partenariat adequats afin de definir une strategie reglementaire appropriee de depot de CMC. Maintenir des normes de qualite elevees et chercher a elever les niveaux de performance grace a l'amelioration continue et a une approche novatrice pour repondre a l'evolution de l'environnement reglementaire. S'assurer que la conformite reglementaire est maintenue et partager les meilleures pratiques et les apprentissages au sein des equipes reglementaires de CMC et d'autres fonctions concernees. S'engager dans les activites d'expert en la matiere de CMC en interne (pour une conformite, une harmonisation et une efficacite accrues). Mettre en oeuvre la strategie reglementaire de CMC pour soutenir les inspections majeures (par exemple, les PAI) avec un soutien de gestion.

Qualifications

Pourquoivous ?



Education

Baccalaureat (formation en sciences de la vie) ou equivalent par experience.
Connaissance

Connaissance des procedures, des systemes et des directives reglementaires Connaissance de la gestion du cycle de vie reglementaire technique Connaissance des produits biologiques Un niveau avance d'anglais et un niveau intermediaire de francais sont exiges pour ce poste, car le titulaire travaillera quotidiennement avec des equipes mondiales et des intervenants externes qui ne parlent pas francais.

Experience

Affaires reglementaires CMC / Gestion technique du cycle de vie, de preference avec des produits biologiques/vaccins, capacite averee a gerer les activites reglementaires typiques, a resoudre des problemes et a obtenir des resultats. Redaction CMC de variations techniques CMC et de composants du module 3, de preference avec des produits biologiques/vaccins, Gestion de projet Processus de controle des modifications Travailler dans un environnement de produits biologiques/vaccins de preference La gestion des soumissions dans l'UE, aux Etats-Unis et sur les principaux marches reglementaires est preferee

Competences

Equipement qualite - Assurer un contenu scientifique rigoureux/qualite/conformite des documents destines aux soumissions reglementaires. Gerer son temps personnel pour atteindre les objectifs a court terme convenus. Capacite a identifier clairement les priorites et a gerer plusieurs taches Excellentes competences en communication, car vous travaillerez avec tous les niveaux de l'organisation ainsi qu'avec les principales parties prenantes externes.

Veuillez noter que cerole

n'a

pas de subordonnes directs, maisvous

gererez

divers projets.





Are you passionate about chemistry, manufacturing, and controls (CMC) for Regulatory Affairs? Our Quebec City office is looking for a manager who is excited by opportunity to apply their skills to the Vaccine site.

Job Purpose:

You would be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products.

Details (Your Responsibilities):

Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities. Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards. Understands, interprets, and will advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications. Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted for lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions. Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy. Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment. Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions. Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency). Will deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.

Qualifications

Why you?


Education

Bachelor's degree (Life Sciences background) or equivalent by experience.

Knowledge

Knowledge of regulatory procedures / systems / guidance's Knowledge of Technical Regulatory Life Cycle Management Knowledge of biological products Advanced level of English and intermediate level of French is required for this position as the incumbent will be working with global teams and external stakeholders daily that do not speak French.

Experience

CMC regulatory affairs / Technical Life Cycle Management, preferably with biologicals/vaccines, proven ability to manage typical regulatory activities, resolve problems and deliver results. CMC authoring of CMC technical variations and Module 3 components, , preferably with biologicals/vaccines, Project Management Change control process Working within Biologics/vaccines environment preferred Managing submissions in EU, US and major regulatory markets preferred

Skills

Quality mindset - Ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions. Manages own time to meet agreed short-term targets. Ability to clearly identify priorities and manage multiple tasks Excellent communication skills as you will be working with all levels of the organization as well as key external stakeholders.

Please note this role does not have any direct reports, however you will be managing various projects.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).


Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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