The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it.
We are utilising our expertise in virology, microbiology, and vaccines to enable novel approaches to prevent and treat infectious disease.
We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules and novel biologics platforms.
Within V&I Regulatory Affairs, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
About the role :
The Labelling Strategy Manger is responsible for the development and implementation of the global labelling strategies for assigned developmental and commercialised products within the V&I portfolio.
The Labelling Strategy Manager applies knowledge of global and local labelling requirements and trends to ensure that essential information regarding the safe and effective use of our products is available to healthcare professionals and patients.
What you will do :
Lead the Product Labelling Team (PLT) in the development and maintenance of high-quality Core Product Information (CPI), EU Quality review of Documents (QRD), US Prescribing Information (PI), Patient Information Leaflets (PIL) and Instructions for Use (IFU) through Senior Leader approval
Contribute to the development of the labelling strategy by interpreting regulations, guidance, and competitor analyses, anticipating, and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider V&I portfolio
Provide labelling expertise to Regulatory Affairs colleagues, cross-functional teams, and AstraZeneca marketing companies, regarding language, placement and regulatory content detail for CPI and market-specific product information, in line with company procedures, regional labelling regulations and guidance
Contribute to the development of labelling negotiation strategies, anticipating HA perspectives.
Provide clarity regarding applicable labelling requirements, expectations, risks, and mitigations for complex situations to relevant stakeholders
Evaluate, interpret, and communicate global regulations and trends on labelling and any business impact these might have on product labelling
Develop and communicate the rationale for labelling strategies to Senior Leaders to enable effective decision making
Contribute to the development of target product labelling (TPL) documents
Contribute to the development of the labelling team by sharing knowledge and mentoring peers
Assist in the development of labelling policies, procedures and SOPs
Must haves :
Bachelor’s degree (or equivalent) in a science or related discipline
Relevant pharmaceutical experience, including regulatory experience
Excellent verbal and written communication skills
Ability to assimilate clinical and scientific information and present it in a concise manner to varied audiences
Keen attention to detail and accuracy
Ability to think strategically; appropriately assess and formulate strategies to manage risk
Demonstrate competencies in building relationships, interpersonal awareness, critical information seeking, rational persuasion and negotiations skills
Desirable skills & experience :
Knowledge of labelling regulations and guidance
Experience in labelling development and / or maintenance, including for vaccines or other antibacterial / antiviral products
Advanced academic degree (PharmD, PhD) or specialized training
Great People want to Work with us! Find out why :
Are you interested in working at AZ, apply today!
AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .
Date Posted
29-May-2024
Closing Date
27-Jun-2024
Talent Acquisition Strategy and Operations Manager
You'll focus on helping the local offices in driving the Firm's people strategy, creating a unique people experience for each individual, and supporting our Firm wide values by working with the core competencies that measure and drive individual and Firm wide success in the marketplace. You'll focus...
Executive Assistant, Global Growth & Strategy
The ideal candidate will have expertise in managing Concur, Microsoft Office, and Coupa systems, along with excellent confidentiality and prioritization skills. Manage information flow and emails from both internal and external sources, organizing and responding accordingly. Strong knowledge and han...
Change and Communications Manager, Deloitte Global Tax and Legal
Do you thrive on developing creative and innovative insights to solve complex challenges? Want to work on next-generation, cutting-edge products and services that deliver outstanding value and that are global in vision and scope? Work with premier thought leaders in your field? Work for a world-clas...
Senior Manager, Climate Strategy and Execution
The Senior Manager, Climate Data and Execution will work with the Climate Change team led by the Vice-President and Head, Global Sustainability, and in close partnership with Data & Analytics, Global Risk Management and other relevant corporate functions, as well as business line partners, to su...
Strategy and Execution Senior Consultant, Deloitte Global Ecosystems and Alliances
Global Ecosystems & Alliances is at the core of the firm's strategy, working hand-in-hand with industries and practice areas to orchestrate expansive business ecosystems of client and alliance relationships to solve the most complex challenges in exponentially powerful ways. The Strategy & Execution...
Manager, Strategy & Analytics
As a Manager, Strategy & Analytics, you’re not just charged with coming up with great strategies that sound good on paper, but are asked to bring them to life through end-to-end delivery, measuring their impact through testing and monitoring, and ultimately being accountable for both P&L and custome...
SOC 2 Manager, Audit & Certification, Deloitte Global Technology 1
This includes, but is not limited to, people with disabilities, candidates from Indigenous communities, and candidates from the Black community in support of living our values, creating a culture of Diversity Equity and Inclusion and our commitment to our AccessAbility Action Plan , Reconciliation A...
Category Product Manager – Strategy and Solutions (Revenue)
The Globe and Mail is a national icon and one of Canada's most recognized media brands. We also invest in our employees' growth through training and mentorship opportunities, enabling you to expand your skills and embrace new challenges. We're seeking a Category Manager with a sharp financial perspe...
Senior Marketing Manager, Technology and Transformation, Global Advisory
The role will focus on creating the strategy and delivering our technology and transformation marketing plans globally, including through our network of member firms and global sectors. The Senior Marketing Manager - Technology and Transformation, reports to the Solutions & capabilities marketing te...
Sr. Marketing Manager, Wireless Acquisition Programs & Strategy
Your mandate is to strategize how we acquire new mobility customers and expand our existing customer base through outbound, inbound and digital tactics. Our team is on a growth journey and the owner of the acquisition campaign strategy is a highly visible role and critical to the success of our busi...