Manager, Regulatory Artwork & Labelling Implementation (RALI)

The Labeling Artwork Manager is responsible for the regulatory role as part of the process for coordination, development, and implementation of new and revised printed labeling for assigned commercial products. You will coordinate and/or lead packaging component labeling content development and support the labeling content development of USPIs and EU centralized labeling.

Accountabilities

• Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
• Point of contact for the management of all labelling/artwork requests that require market/regulatory approval in US and EU centralized procedure, such as the creation, approval, and implementation of commercial printed labeling in collaboration with various functions.
• Coordinate and/or lead the development and lifetime maintenance of packaging component labeling for commercial products, including introduction of new packs and new product launches, updates to existing packs, and mock-ups for regulatory submissions.
• 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, 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.
• 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 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 subteams.

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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is a place built on courage, curiosity, and collaboration. We make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions, and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research, we have built an unrivaled scientific community both internally and externally. Fusing academia and industry, we have united some of the world's foremost medical centers. Working seamlessly and inclusively together, we expedite research in some of the hardest-to-treat cancers. Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.

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