Site Name: Mississauga Milverton Drive
Posted Date: Dec 19 2024
*Posting expires on Friday, January 10, 2025 at 23:59 Eastern Time
Job Purpose:
As a key player in ensuring the successful submission of regulatory documents, you will bring your comprehensive publishing expertise to the forefront, managing the electronic filing of regulatory submissions for Canadian GSK products. This position requires overseeing multiple submissions to ensure compliance with Health Canada's submission deadlines. With your deep regulatory knowledge and understanding of the product lifecycle, you will address challenges related to submission CTD structure, Health Canada's validation requirements, guidelines, and policies. You will independently assess and resolve any submission-related issues that could affect compliance with Health Canada's standards. Get ready to drive success by navigating complex regulatory landscapes with precision and confidence!
Details (Your Responsibilities):
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Provides publishing, word processing and document management activities for the preparation of all regulatory submissions in electronic formats for Canadian GSK products.
Manages multiple submissions to ensure Health Canada submission deadlines are met.
With/without guidance, maps and inputs cross-references and annotations including hyperlinks when appropriate.
Responsible for independently assessing and resolving any submission related issues impacting compliance with Health Canada requirements (submission structure, formatting, compliance with guidelines and policies), using regulatory knowledge and understanding of the product lifecycle.
Builds relationships with local and global contacts and proactively participates in the planning of submission.
Trains and mentors new staff
Other Responsibilities:
Local expert on specialized publishing software applications, document management systems
Proactively addresses submission publishing or software related issues and takes the lead to problem solve, summarize and communicate.
Lead user of RA systems, participating in the development of new systems or changes to existing systems, identifying business/user requirements, testing and participating in the completion of appropriate computer systems documentation
Contributes to systems strategy development in conjunction with manager and local IT.
Performs assigned tasks associated with document and regulatory fee management.
Responsible for maintenance activities on behalf of RA such as custodian or administrator function, providing access control for RA systems, creating or updating RA submission templates, managing agency correspondence in RA group mailbox, distribution and posting of Product Monographs, submission planning/assignment of resources.
Leads and/or participates and provides input on department teams e.g. continuous improvement, Health Canada guidances
Reviews projects to ensure compliance with applicable Health Canada, Industry & GSK codes and guidelines in alignment with Business needs.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
University degree, preferably with a strong emphasis in information technology
3-5 years' experience in regulatory eCTD publishing of Canadian submission dossiers
Strong computer expertise; ability to quickly adapt to new technology. Experience with eCTD publishing tools, Veeva Vault and basic understanding of HTML, XML mark-up.
Specific knowledge about regulatory affairs and the drug development process
Excellent oral and written communications skills with the ability to present to small and large group.
Process improvement mindset.
Agile with the ability to react quickly, provide creative solutions to problems and navigate change.
Accountable to simultaneously work on multiple projects and to meet tight timelines.
Excellent attention to detail and accuracy of work
Act with integrity and demonstrate a strong quality mindset.
Ability to provide and receive feedback, raise issues, share experiences and lessons learned.
Proactive and seeks to constantly learn and develop. Ensures that skills meet changing business needs.
Collaborative with the ability to work with diverse group of individuals in a team and to express opinions, including as part of group discussions.
Open to diverse ideas, styles and perspectives
#LI-Hybrid
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 committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. 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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