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Director of Regulatory Affairs and Quality
3 months ago
Site Name:
Mississauga Milverton Drive
Please note:
this is a month contract
Hybrid role from our Mississauga office.
Responsible for the effective functioning of the internal control framework including elements such as training, written standards, management monitoring, risk and issues management and inspection/audit readiness
Develops regulatory strategies to implement, or improve departmental compliance
Ensures compliance with applicable Health Canada, industry, and GSK codes and guidelines in alignment with business needs
Builds trust with Health Canada contacts to resolve product related issues impacting compliance activities
Communicates with and influences multiple local and global functions, to achieve regulatory objectives
Identifies and responds to issues related to assigned projects
Interprets Canadian regulations, guidelines and policies as they apply to GSK regulatory activities
Mentors junior staff
in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
Extensive Canadian regulatory affairs experience leading compliance activities
Must possess a thorough understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies
Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues
Agile and able to effectively navigate change
Demonstrated ability to develop effective regulatory strategies aligned with business objectives
Working knowledge of global regulatory agencies and their practices
Fully developed project management skills
Must act with integrity and demonstrate a strong and effective risk management perspective
~ Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs
Strong commitment to quality mindset
Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook
Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.
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).
GSK is an equal opportunity employer committed to diversity and inclusion. 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- .
Please do not send resumes to this e-mail and instead apply through the online application process of this posting.Important notice to Employment businesses/ Agencies
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 GSK's 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.
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