Associate Director, Regulatory Artwork & Labelling Implementation (RALI)

Are you ready to make a difference in the world of regulatory labeling? As the Labelling Artwork Associate Director, you'll play a pivotal role in coordinating, developing, and implementing new and revised printed labeling for our commercial products. You'll lead packaging component labeling content development and support the creation of USPIs and EU centralized labeling. Your expertise will ensure that our transformative science reaches those in need efficiently and effectively.

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.

• Understand industry labeling trends related to packaging and labeling content and implementation.

• Interpret US and EU labeling regulations and guidance, determining company impact.

• Contribute the regulatory labeling perspective in support of novel packaging design initiatives.

• Ensure proper version control and document integrity of packaging component labeling.

• 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 cross-functional subteams.

Essential Skills/Experience:

• University Degree in Science or related discipline.

• 3-5 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)

Desirable Skills/Experience:

• Experience in packaging/artwork labeling development and/or maintenance.

• US/EU experience.

At AstraZeneca, we are driven by science, success, and achieving our goals through innovative approaches. Our inclusive environment fosters collaboration across global teams, unlocking regulatory knowledge to bring life-changing medicines to patients swiftly. We embrace change as an opportunity to learn, grow, and evolve, ensuring our transformative science is transformed into real value for patients. Join us in breaking down barriers, driving efficiency, and playing a key role in delivering rapid global approvals.

Ready to make an impact? Apply now to join our team!

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.