Manager- Regulatory Artwork

3 months ago

Mississauga, Canada AstraZeneca Full time

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices **3 days a week**. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

We are now looking for a passionate colleague to join our team as a **Labeling Artwork Manager for a permanent position**.

The Regulatory Artwork & Labeling Implementation team (RALI) at AstraZeneca is part of the Global Regulatory Affairs organisation and focuses on both the development, maintenance and implementation of and regulatory information on packages for Health Authority approval, We are covering products for the EU and US markets.

The Global Labeling Artwork Manager is responsible for the regulatory role towards creation of the printed material for products under development, updating of existing artworks for already marketed products, liaising with Marketing Companies in Europe as well as packaging sites within production.

**What you’ll do**
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Point of contact for the management of all labeling/artwork updates that require market/regulatory approval in US and EU centralised procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions
- Coordinates and leads the development and mock-ups for regulatory submissions. including planning and introduction of new packs and new product launches into market.
- Provide tactical and strategic guidance to regulatory teams and to product labeling teams regarding regulatory requirements for packaging and artwork components.
- Understand industry labeling trends related to packaging and labeling content and implementation, reviewing competitor and other labeling
- Interpret US and EU labeling regulations and guidance, determining company impact and providing comments as appropriate
- Contribute the regulatory labeling perspective in support of novel packaging design initiatives

**Essential for the role**
- University Degree in Science or related discipline
- Relevant pharmaceutical experience, including regulatory experience, preferably working with packaging and artwork management and labeling
- Knowledge of labeling regulations and guidance
- Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures

**Desirable for the role**
- Experience in packaging labeling development and/or maintenance.

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel

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