Associate Director ORSSE Labelling

The Associate Director ORSSE Labelling provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross-functional Product Labelling Teams (PLT). This individual leads the development and implementation of the labelling strategy and maintenance of Core Product Information and United States (US)/European Union (EU) Market Product Information (MPI) for assigned AstraZeneca (AZ) marketed or pipeline products. The individual contributes to the development of the labelling group by sharing knowledge and mentoring peers.

Accountabilities
• 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.
• Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, 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 AZ portfolio.
• 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.
• Leads the development of labelling 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 guidance.
• Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations.
• Evaluates, interprets, and communicates global regulations and trends on labelling and any business impact these might have on product labelling.
• Ensures appropriate communication across Labelling subfunctions.
• Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision-making.
• Leads the development of target labelling documents as appropriate.
• Assists in the development of labelling 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 labelling
• Knowledge of labelling regulations and guidances
• Excellent verbal and written communication skills
• Keen attention to detail and accuracy
• Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.
• Ability to assimilate clinical and scientific information and present it in a concise manner
• Ability to think strategically, appropriately assess risks and formulate strategies to manage risk
• Must demonstrate competencies in:
  - 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)

Desirable Skills/Experience
* Experience in Labelling development and/or maintenance
* Knowledge of major markets Labelling regulations
* 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.

At AstraZeneca, we are driven by a shared vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Empowered at every level, we make bold decisions driven by patient outcomes. Join us in our mission to improve the lives of millions with cancer.

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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 authorization and employment eligibility verification requirements.