Nom du site: Mississauga Milverton Drive
Data de publication: Jan 2 2025
Join GSK, a global leader in healthcare innovation! We're seeking a Principal Submission Specialist to drive regulatory excellence and support groundbreaking research. Be part of a dynamic team with a global impact. Apply now and help shape the future of healthcare!
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Responsible for on-time delivery of Module 2 (QOS) and Module 3 (CMC Standalone and Non-Standalone) electronic applications to Regulatory Authorities for submission types ranging from major, original NCE or Biologic applications through to lifecycle submissions required to maintain application’s registered status and fulfil regulatory obligations.
- Integral member of the Global Regulatory Matrix Teams for high profile R&D projects. Represents CMC Publishing and negotiates agreements with stakeholders on specific technical aspects of major submissions and timelines for delivery which best support the needs of the R&D Project.
- Accurately estimates scale and timing of publishing tasks and collaborates with Global Publishing Leads, Global Submission Managers, and staff at GRCs to plan and resource for delivery against aggressive timelines.
- Ensures that CMC documents provided by authors are submission ready and formats to GSK standards as required.
- Maintains knowledge of relevant Regulatory Authority rules and guidance associated with different formats of regulatory submissions in multiple regions (e.g. eCTD).
- Building electronic submissions with standard industry software, using validated processes, and adhering to SOPs and Working Instruction documents.
- Advises and guides CMC Regulatory Exec’s on submission structure and publishing/handoff approach.
- Assists authors with more complex or non-routine content preparation of document management procedures. Provides training when required to Authors populating CMC Templates during Major Marketing Applications.
- Manages multiple projects/activities at different stages of development at any one time to ensure timely submission or process/system integrity.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment
- Formatting of MS Word documents ensuring GSK requirements and standards are met.
- Knowledge of document management and publishing software and utilities.
- Knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide.
- Project management skills and ability to oversee and prioritize multiple activities across one or more sites for multiple customers.
- Strong sense of urgency, able to prioritize effectively such that key issues or emerging high priority matters are handled in a timely and effective way.
- Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Ability to make decisions based on technical knowledge and experience within a regulated framework.
- Ability to function as a team player within a matrixed organization.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
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-GSK
GSK est un employeur prônant l'égalité des chances en matière de diversité et d'inclusion. Nous accueillons les candidatures de tous les individus qualifiés qui postulent aux opportunités de carrière que nous proposons. GSK s'engage à prendre en charge les personnes présentant des handicaps. Si vous avez besoin de dispositions particulières à n'importe quelle étape du processus de candidature ou si vous désirez d'autres informations sur nos politiques de dispositions particulières, veuillez nous contacter à l'adresse canada-recruitment@gsk.com. Veuillez ne pas envoyer de curriculum vitae à cette adresse électronique, mais postulez plutôt à cette offre d'emploi via le processus de candidature en ligne.
Avis important à l'attention des cabinets de recrutement/agences d'intérim
GSK n'accepte pas de candidatures recommandées provenant des cabinets de recrutement/agences d'intérim pour les postes à pourvoir sur ce site. Tous les cabinets de recrutement/agences d'intérim doivent contacter le service des ressources humaines ou les Achats de GSK pour obtenir une autorisation écrite préalable avant de présenter des candidats à GSK. L'obtention d'une autorisation écrite préalable est une condition préalable à tout accord (oral ou écrit) entre le cabinet de recrutement/l'agence d'intérim et GSK. En l'absence d'une autorisation écrite, toute action de la part du cabinet de recrutement/l'agence d'intérim sera jugée comme ayant été effectuée sans le consentement ou l'accord contractuel de GSK. GSK ne pourra par conséquent pas être tenu responsable des frais résultant de telles actions ou des coûts découlant de candidatures recommandées par des cabinets de recrutement/agences d'intérim pour les offres d'emploi publiées sur ce site.
