Global Labeling Manager

7 days 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.

Do you have a background in **Regulatory Affairs and Labeling**? Are you a skilled negotiator who is great at building relationships? Would you like to put your skills to use in a role that will ultimately benefit many of our patients?

If so, why not join our **Respiratory and Immunology (R&I) Regulatory Labeling team** to get involved in shaping global regulatory labeling strategies and support the research, development and commercialization of our R&I products across the portfolio

Getting medicines to market and to the end users who will benefit from them really is what we are all about here at AstraZeneca. Our skilled Regulatory teams are key to that, ensuring that the medicines we produce meet the different requirements to licence them in countries across the world. The Labeling/Labeling strategy teams work on ensuring that the information on the safe and effective use of these medicines reaches the end users - Health care Professionals and patients.

**The role**:
We are now seeking a new member to join our team in the role **as Labeling Strategy Manager**. This role can be located in **Mississauga (Canada)**.

**What You’ll Do**:
Working in the role as Labeling Strategy Manager, you will provide labeling document management skills and regulatory labeling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT) with guidance from experienced team members.

This role leads the development/implementation of the labeling strategy and maintenance of Core Product Information and United States (US) / European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products.

**Your main accountabilities/responsibilities**:

- Ensure that the labelling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Interpret regulations, competitor analyses, and anticipating / communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
- Lead the PLT in the preparation and updates of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
- Contribute/ lead the development of labelling negotiation strategies, anticipating Health Authorities perspectives.
- Provide labeling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional regulations and guidance.
- Evaluate, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labeling.
- Ensure appropriate communication across labeling sub-functions.
- Support and communicate the labeling rationale to Senior Leaders to enable effective decision making.

**Essential Requirements**:

- Bachelor’s degree (or equivalent) in Science or related discipline
- Demonstrative experience, including regulatory experience, in a pharma company, preferably working with labelling
- Knowledge of labeling regulations and guidances
- Excellent verbal and written communication skills
- Keen attention to detail and accuracy
- Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

**Preferred Qualifications**
- Advanced academic training is highly desirable (PharmD, PhD)
- If you have knowledge of major market labelling regulations, this will be an advantage

**Why AstraZeneca?**

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start o

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