Labelling Artwork Associate Director

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.

We are now looking for a passionate colleague to join our team as a **Labelling Artwork Associate Director for a permanent position**. The role is based at AstraZeneca’s dynamic R&D site in **Barcelona**.

**Introduction to role**

The Labelling Artwork Associate Director is responsible for the regulatory role in coordinating, developing, and implementing new and revised printed labeling for assigned commercial products. This role involves leading packaging component labeling content development and supporting the labeling content development of USPIs and EU centralized labeling.

**What you’ll do**
- Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
- Act as the point of contact for managing all labelling/artwork requests requiring market/regulatory approval in US and EU centralized procedures, including 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 the introduction of new packs, 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 in early development.
- 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 subteams.

**Essential for the role**
- University Degree in Science or related discipline
- 5 years pharmaceutical experience, preferably regulatory experience, preferably working with artwork management and labeling
- 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)

At AstraZeneca, we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Our inclusive, diverse, and bold environment empowers us to be the best we can be. We thrive on collaboration, sharing knowledge, and supporting each other to succeed. Our commitment to innovation drives us to find new ways to deliver better outcomes for patients.