Labelling Project Manager

Job Description Summary

Position: Regulatory Affairs Labelling Project Manager
Location: Montreal, #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the role:
Exciting new opportunity within Novartis Regulatory Affairs as Labelling Project Manager in our Labelling & Packaging team! In this position, you will play a crucial role in leading various projects, preparing product labelling and packaging submissions and ensuring they comply with Health Canada regulations, meet customer and business needs and industry standards, while leveraging your communication, negotiation, organizational and artwork coordination skills.
This role will work directly with the Novartis Regulatory Affairs team and reports to the RA Lead, Labelling & Packaging.
Temporary position: 12 months

Job Description

Key responsibilities:

• Create and maintain regulatory compliant, timely, and up-to-date labelling documents for Novartis products, according to local and global regulatory plans and regulations.
• Annotate, initiate, and manage Artwork Requests for safety updates, launches, text changes, site transfers, technical changes, and reworks (mockups and production).
• Review and approve artwork proofs according to local and global policies.
• Liaise with local Regulatory Program Managers (RPM) and Regulatory Therapeutic Area Leads (RTAL) to ensure high quality and timeliness of Canadian regulatory submissions.
• In collaboration with RPMs or RTALs, develop strategies for timely and successful submissions as it relates to artwork.
• Prepare regulatory submission documentation related to artwork and labelling (e.g., annotated artwork materials, forms, Notes to Reviewer, and HAQ responses).
• Track, maintain, and ensure high-quality artwork for all local packaging components of Novartis pharmaceutical products.
• Monitor trends in Health Authority requests related to artwork and labelling and ensure these are addressed in upcoming submissions.
• Communicate new guidelines, policies, and regulations impacting artwork and labelling to local and global teams.
• Support the compliance function of the Regulatory Affairs department in various tasks and responsibilities.

What you’ll bring to the role:

Essential:

• Excellence in ensuring high quality, compliant and timely regulatory product labelling components are created, revised and launched across various products by interacting with local and global colleagues.
• Compliant oversight of key packaging-related and inter-departmental projects (e.g. GTIN/Barcoding/Serialization).
• Support GDD Canada through high quality contributions to RA local and regional leadership team, and local GDD areas, as well as local departments outside of GDD (e.g., QA for audits/inspections/SOP handling; SCM for planning of launches etc.)
• Clearly demonstrates Novartis Values and Behaviors in all tasks and interactions

Desirable:

• Regulatory affairs experience, labelling an asset

• Pharmaceutical/biotech industry experience

Skills Desired

Cross-Functional Teams, Detail-Oriented, Labeling Documentation, Labeling Regulations, Operational Excellence, Regulatory Compliance, Safety