Responsable mondial des affaires réglementaires â CMC / Global Regulatory Affairs CMC Manager
Responsable mondial des affaires réglementaires â CMC / Global Regulatory Affairs CMC Manager
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Job Description
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tes-vous passionn par la chimie la fabrication et les contrles (CMC) dans le domaine des affaires rglementaires Notre bureau de Qubec est la recherche dun gestionnaire enthousiaste lide dappliquer ses comptences sur notre site de vaccination.
Objectif du poste:
Vous serez responsable des activits rglementaires de CMC dans la phase avance du dveloppement et/ou de la gestion du cycle de vie commercial des produits GSK.
Dtails (vos responsabilits):
Responsable des activits rglementaires mondiales de CMC pour les projets assigns et capable de rpondre facilement aux vnements et aux priorits changeants.
Responsable de llaboration de la stratgie de CMC avec le soutien de la direction pour les documents de soumission de CMC afin de soutenir les activits de gestion du cycle de vie des produits commercialiss conformment aux normes rglementaires et scientifiques applicables.
Comprendre interprter et conseiller les quipes sur les rglementations les directives les procdures et les politiques relatives la fabrication et au contrle des produits mdicinaux afin dacclrer la soumission lexamen et lapprobation des demandes mondiales de CMC.
Sassurer que tous les aspects rglementaires appropris de CMC pour la libration du produit sont en place afin dassurer la continuit de lapprovisionnement du march. Garantir que les informations soumises pour les soumissions de maintenance du cycle de vie rpondent aux exigences rgionales ce qui permet une flexibilit maximale en matire dapprovisionnement de production et de qualit avec un minimum de questions imprvues.
Travailler au sein dquipes de projet matricielles interfonctionnelles avec des collgues de la rglementation du dveloppement de la qualit et de la fabrication assurant une interaction et un partenariat adquats afin de dfinir une stratgie rglementaire approprie de dpt de CMC.
Maintenir des normes de qualit leves et chercher lever les niveaux de performance grce lamlioration continue et une approche novatrice pour rpondre lvolution de lenvironnement rglementaire.
Sassurer que la conformit rglementaire est maintenue et partager les meilleures pratiques et les apprentissages au sein des quipes rglementaires de CMC et dautres fonctions concernes.
Sengager dans les activits dexpert en la matire de CMC en interne (pour une conformit une harmonisation et une efficacit accrues).
Mettre en uvre la stratgie rglementaire de CMC pour soutenir les inspections majeures (par exemple les PAI) avec un soutien de gestion.
Qualifications
Pourquoi vous
ducation
Baccalaurat (formation en sciences de la vie) ou quivalent par exprience.
Connaissance
Connaissance des procdures des systmes et des directives rglementaires
Connaissance de la gestion du cycle de vie rglementaire technique
Connaissance des produits biologiques
Un niveau avanc danglais et un niveau intermdiaire de franais sont exigs pour ce poste car le titulaire travaillera quotidiennement avec des quipes mondiales et des intervenants externes qui ne parlent pas franais.
Exprience
Affaires rglementaires CMC / Gestion technique du cycle de vie de prfrence avec des produits biologiques/vaccins capacit avre grer les activits rglementaires typiques rsoudre des problmes et obtenir des rsultats.
Rdaction CMC de variations techniques CMC et de composants du module 3 de prfrence avec des produits biologiques/vaccins
Gestion de projet
Processus de contrle des modifications
Travailler dans un environnement de produits biologiques/vaccins de prfrence
La gestion des soumissions dans lUE aux tats-Unis et sur les principaux marchs rglementaires est prfre
Comptences
Equipement qualit - Assurer un contenu scientifique rigoureux/qualit/conformit des documents destins aux soumissions rglementaires.
Grer son temps personnel pour atteindre les objectifs court terme convenus. Capacit identifier clairement les priorits et grer plusieurs tches
Excellentes comptences en communication car vous travaillerez avec tous les niveaux de lorganisation ainsi quavec les principales parties prenantes externes.
** Veuillez noter que ce rle na pas de subordonns directs mais vous grerez divers projets.
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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 sharesbest-practices and learnings within the CMC Regulatory teamsand other impacted functions.
- Engages inCMCSubject Matter Expert activities internally (for increased complianceharmonisationand efficiency).
- Will deliver CMC regulatory strategy to support major inspections (egPAIs) with managerial support.
Qualifications
Why you
Education
- Bachelors degree (Life Sciences background) or equivalent by experience.
Knowledge
- Knowledge of regulatory procedures / systems / guidances
- 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 its 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 .Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Required Experience:
Exec
Employment Type
Full-Time
