Summary
About the Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
