Manager, Global Labelling Strategy

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 Manager, Global Labelling Strategy provides regulatory labeling expertise and guidance, typically for more complex drug projects and across oncology and cross-functional teams. This position will contribute to developing and crafting the strategic direction of the labeling 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 labeling group by sharing knowledge, mentoring peers, and advising the respective Global Labeling Oncology Group Manager to ensure appropriate project and resource planning.

Accountabilities

• Ensures that the labeling process is followed through the lifecycle of the product.
• Ensure all work is performed in accordance with established procedures, regulatory requirements, and GxPs.
• 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.
• 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 labeling.
• Leads labeling negotiation strategies, anticipating health authority perspectives.
• Provides labeling 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 labeling regulations, and guidance.
• Provides clarity regarding applicable labeling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
• Evaluates, interprets, and communicates global regulations and trends on labeling and any business impact these might have on product labeling.
• Able to justify and communicate the labeling rationale to Senior Leaders to enable effective decision-making.
• Develop labeling documents, policies, procedures, and SOPs.

Essential Skills/Experience

• University Degree in Science or related discipline
• 3 to 5 years pharmaceutical experience, including regulatory experience, preferably working with labeling
• Knowledge of labeling regulations and guidance
• Excellent verbal and written communication skills
• Keen attention to detail and accuracy
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

Desirable Skills/Experience

• Advanced academic training is highly desirable (PharmD, PhD)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is a place built on courage, curiosity, and collaboration. We make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Pioneers of collaborative research, we have built an unrivaled scientific community both internally and externally.

Fusing academia and industry, we have united some of the world's foremost medical centers. Working seamlessly and inclusively together, we expedite research in some of the hardest-to-treat cancers. Have the opportunity to build a rewarding and meaningful career as part of the team committed to improving the lives of millions with cancer.

Ready to make a difference? Apply now!

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.