Labelling Strategy Director - Late CVRM

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 Labelling Strategy Director provides regulatory labelling expertise and guidance, typically for more complex drug projects and across specific therapy/disease areas and cross-functional teams. This position will contribute to developing and crafting the strategic direction of the labelling component of the regulatory strategy for sophisticated projects and/or disease areas along with the maintenance of Core Product Information and US/EU Market Product information (MPI) for assigned AstraZeneca marketed or pipeline products. The individual has a key role in the labelling group by sharing knowledge, mentoring peers, and advising the respective Labelling Therapy Area Director Group Manager to ensure appropriate project and resource planning.

This role can be based at either of AstraZeneca's dynamic R&D sites in Gothenburg (Sweden), Gaithersburg (US), Macclesfield (UK) or Cambridge (UK).



What You'll Do:

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Ensures that the labelling process is followed through the lifecycle of the product.
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Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
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Develop the strategy to align with the overall product regulatory strategy by interpretation of 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 AZ portfolio.
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Leads the PLT in the preparation and maintenance of high quality Core Prescribing Information, EU Quality Review of Documents, US Prescribing Information, Instructions For Use through to Senior Leader approval with the aim of achieving advantageous labelling.
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Leads labelling negotiation strategies, anticipating health authority perspectives.
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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 guidance.
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Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
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Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
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Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
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Develop labelling documents, policies, procedures and SOPs.



Essential Requirements:

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Bachelor's degree in Science or related discipline
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At least 5 years of pharmaceutical experience, including regulatory experience, preferably working with labelling
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Knowledge of labelling regulations and guidances
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Excellent verbal and written communication skills
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Keen attention to detail and accuracy
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Ability to think strategically, appropriately assess risks and formulate strategies to manage risk



Preferred Qualifications:

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Advanced academic training is highly desirable (PharmD, PhD)



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, groundbreaking cutting edge methods and bringing unexpected teams together. 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. Welcome with your application no later than May 8th. We will review the applications continuously so please apply as soon as possible.



Salary: Competitive

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Covid-19 Resources