At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Job Description
The Global Labeling Delivery Packaging/Artworks Manager/Associate Director 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. Coordinates and/or leads packaging component labeling content development and supports the labeling content development of USPIs and EU centralized labeling.
Typical Accountabilities
Accountabilities/Responsibilities:
- 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
- Coordinates and/or leads 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 labelling
- 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 sub teams
Education, Qualifications, Skills and Experience
Essential
Minimum requirements:
- University Degree in Science or related discipline
- 1-2 or 3-5 years (depending on role) pharmaceutical experience, preferably regulatory experience, preferably working with 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 distil an issue to its key components and suggest solutions)
- Interpersonal Awareness (aware of how actions affect other people)
Preferred Background:
Desirable
- Experience in packaging labeling development and/or maintenance