Global Labelling Strategy Manager – Vaccines and Immune Therapies

4 weeks ago


Mississauga, Canada AstraZeneca Full time

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

  • Mississauga, Canada AstraZeneca Full time

    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...


  • Mississauga, Canada AstraZeneca Full time

    Join the Vaccines and Immune Therapies (V&I) group at AstraZeneca, where we are pushing the boundaries of science to deliver life-changing medicines to patients. As the Global Labelling Strategy Manager, you will be responsible for the development and implementation of global labelling strategies for our developmental and commercialised products within the...


  • Mississauga, Ontario, Canada AstraZeneca Full time

    Join the Vaccines and Immune Therapies (V&I) group at AstraZeneca, where we are pushing the boundaries of science to deliver life-changing medicines to patients. As the Global Labelling Strategy Manager, you will be responsible for the development and implementation of global labelling strategies for our developmental and commercialised products within the...


  • Mississauga, Canada AstraZeneca Full time

    **Opportunity**: Global Development Scientist - The Vaccines and Immune Therapies **Business Area**: Vaccines & Immune Therapies Late Development **Locations**: Barcelona (Spain), Gaithersburg (USA), Gothenburg (Sweden), Mississauga (Canada) **Salary**: Competitive, with excellent benefits Do you have expertise in, and passion for clinical drug...

  • Global Pricing

    1 month ago


    Mississauga, Canada AstraZeneca Full time

    Global Pricing & Market Access Director, Vaccines & Immune Therapy  At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to...

  • Global Pricing

    4 weeks ago


    Mississauga, Canada AstraZeneca Full time

    Global Pricing & Market Access Director, Vaccines & Immune Therapy  At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts...


  • Mississauga, Canada AstraZeneca Full time

    **About us**: Are you passionate about **science** and experienced within **drug development** and **regulatory affairs**_? _Would you like to combine your **project management skills** with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...

  • Global Pricing

    1 month ago


    Mississauga, Canada AstraZeneca Full time

    **Global Pricing & Market Access Director, Vaccines & Immune Therapy** At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to...


  • Mississauga, Canada AstraZeneca Full time

    At **AstraZeneca**, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. The **Global...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca , we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. The Global Labeling...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca , we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. The Global Labeling...


  • Mississauga, Canada AstraZeneca Full time

    About us: Are you passionate about science and experienced within drug development and regulatory affairs Would you like to combine your project management skills with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That...


  • Mississauga, Canada AstraZeneca Full time

    About us: Are you passionate about science and experienced within drug development and regulatory affairs Would you like to combine your project management skills with your experience of working cross functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That...


  • Mississauga, Canada AstraZeneca Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal...


  • Mississauga, Canada AstraZeneca Full time

    **Job Description - Principal Patient Safety Scientist, Vaccines & Immune Therapies** **Location - Onsite in Gaithersburg MD or Waltham MA or Mississauga Canada** 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...