Manager, Regulatory Artwork & Labelling Implementation (RALI)
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.
Introduction to role
Are you passionate about ensuring the accuracy and compliance of product labeling? As a Labeling Artwork Manager, you will play a crucial regulatory role in coordinating, developing, and implementing new and revised printed labeling for our commercial products. You will lead packaging component labeling content development and support the creation of USPIs and EU centralized labeling.
Accountabilities
- Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
- Serve as the point of contact for managing all labeling/artwork requests requiring market/regulatory approval in US and EU centralized procedures.
- Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products.
- Provide tactical and strategic guidance to product labeling teams regarding regulatory requirements for packaging component labeling.
- Understand industry labeling trends related to packaging and labeling content and implementation.
- 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.
- Ensure proper version control and document integrity of packaging component labeling, printed labeling artworks, and other assigned labeling documents.
- Originate precedent searches, create and maintain labeling comparisons, and assist in the analysis of competitive labeling.
- Interact with Marketing Company colleagues regarding global artworks as appropriate.
- Process and prepare all US Final Printed Labeling and required EU specimens for submission.
- Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function.
- Liaise with relevant stakeholders as needed to resolve critical labeling issues.
- Represent functional expertise at relevant department meetings and relevant cross-functional sub-teams.
Essential Skills/Experience
- University Degree in Science or related discipline
- 1-3 years of pharmaceutical experience, preferably regulatory experience, preferably working with labeling and packaging/artwork management
- Knowledge of labeling regulations and guidance’s
- Keen attention to detail and accuracy
- Excellent verbal and written communication skills
- Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
- Ability to think strategically, appropriately assess risks, and formulate strategies to manage risk
- Must demonstrate competencies in:
- Building Relationships (works well across formal and informal networks)
- Negotiation Skills (good listener; able to build a consensus)
- Critical Information Seeking (works well across formal and informal networks)
- Rational Persuasion (able to distill an issue to its key components and suggest solutions)
- Interpersonal Awareness (aware of how actions affect other people)
Desirable Skills/Experience
- Experience in packaging/artwork development and management as well as labeling development and/or maintenance.
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
#LI-Hybrid
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
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