About The Position
The Associate Director, Labelling and Artwork - Regulatory is responsible for strategic oversight of labelling activities and the creation of all final artwork and printed components for product packaging materials. Working closely with Global Labelling Services, they ensure accuracy of regulatory and technical requirements. The Associate Director serves as the regulatory point of contact with local stakeholders and Global Regulatory Affairs, and partners effectively with regulatory clinical units. They may also undertake additional activities, including projects and leading team initiatives.
Requirements
- Hold a Bachelor's degree in health sciences, or engineering.
- Minimum 10 years of experience and demonstrated success in Regulatory Affairs.
- Strong communication and time management skills.
- Ability to work independently with minimal supervision.
- Strong collaboration and teamwork skills.
- Demonstrated knowledge and understanding of the Food and Drugs Act and Regulations (Health Canada), and ability to interpret.
- Demonstrated knowledge and understanding of regulatory affairs concepts and terminology.
- Development of local procedures for labelling activities.
- Demonstrated understanding of the company’s global Regulatory Affairs organization, processes, and compliance expectations.
- High-level understanding of business needs and labelling strategy.
- High-level understanding and ability to interpret Health Canada regulatory requirements and guidance documents impacting artwork and labelling submissions.
- In-depth understanding of how a pharmaceutical company operates, including the roles of other departments and their interactions with Regulatory Affairs.
- Advanced ability to effectively communicate verbally and in writing with various types of stakeholders (clinical, commercial, government), with a demonstrated understanding of the importance of accurate and effective communications and potential impacts of poor communication.
- Advanced presentation skills and ability to tailor presentations to various audiences.
- French (written and verbal) language requirement.
- Excellent word processing, presentation and spreadsheet application skills.
- Advanced user of large project management databases.
- Demonstrated experience with computer interface systems.
- Visible commitment to the department and the company.
- Strong ability to explain and defend decisions/positions and to take a stand in the best interest of the company.
- Excellent time management, organization and planning skills.
- High level of accuracy and quality of work.
- Excellent collaboration skills.
- Demonstrated ethics and integrity, with no compromise on compliance.
Responsibilities
- Identify and critically assess the impact of new and/or revised Health Canada regulations and/or guidelines on labelling strategies including serialization and track & trace, and advise internal and global stakeholders on the appropriate course of action.
- Provide leadership and oversight of regulatory labelling projects for all Canadian regulatory submissions.
- Manage labelling artwork for all regulatory filings, in collaboration with Project Managers and third-party vendors as required.
- Lead key negotiations with Health Canada related to all labelling issues.
- Ensure all artwork is compliant with the Food and Drugs Act and Regulations, all relevant Canadian guidelines, and company policies.
- Ensure management of all GS accounts and that all company product-related information and images are accurate and up to date, including GTINs and barcodes.
- Be accountable for labelling workload planning and provide proactive recommendations to manage periods of activity exceeding capacity to ensure delivery of labelling project tasks.
- Act as the subject matter expert for labelling and artwork packaging system(s) (e.g., Global Life Sciences Automation Management System (GLAMS) and ensure Regulatory Affairs users are adequately trained and able to work within these systems.
- Content expert and primary point of contact for local Manufacturing, Human Health and Support Functions.
- Collaborate and support requests from various stakeholders impacting labelling including, but not limited to, Legal requests (trademarks, company name), customer feedback and alignment of labelling strategies with Human Health strategies, while ensuring regulatory compliance.
- Content expert and primary point of contact for global.
- Provide strategic input to network-wide changes that may impact multiple products, as well as technical changes (e.g., equipment changes at packaging site).
- Actively participate and/or lead global system improvement initiatives.
- Perform other activities as requested by the Director, Regulatory Affairs - Chemistry Manufaturing & Controls.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
