Global Labeling Manager

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 outstanding skills with those of people from all over the globe.

As the Global Labelling Strategy Manager, you will provide regulatory labelling expertise to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET) and cross functional Product Labelling teams, with guidance from the Global Labelling Director. This role contributes to the development of the labelling strategy and leads the maintenance and implementation of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products.

What you'll do
  • Ensures that the labelling process is followed through the lifecycle of the product
  • Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
  • Contributes to the development of the labelling strategy, in line with the overall regulatory strategy for the product, applying knowledge and understanding of labelling regulations, guidances and competitor analyses with/under guidance from the Global Labelling Director
  • Contributes to negotiation strategies, anticipating HA perspectives
  • Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidances.
  • Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling
  • Leads the PLT in the preparation and maintenance of high quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
  • Provides clarity regarding applicable labelling requirements and expectations to relevant partners, including risk insight and proposing mitigations
  • Ensures appropriate communication across Global Labelling Group sub-functions
  • Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
  • Contributes to the development of target labelling documents, as appropriate under the supervision of the Director


Minimum Requirements
  • University Degree in Science or related field
  • At least 1 year of experience working with labelling
  • Knowledge of labelling regulations and guidance
  • Excellent verbal and written communication skills
  • Keen attention to detail and accuracy
  • Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating in diverse cultures.


Preferred
  • Experience in Labelling development and/or maintenance
  • Knowledge of major markets Labelling regulations
  • Advanced academic training is highly desirable (PharmD, PhD)


Skills
  • 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)


Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what's next!

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them

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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