Director, Labeling Strategy

at  AstraZeneca

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 Strategy Director provides regulatory labeling 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 labeling component of the regulatory strategy for sophisticated projects and/or disease areas along with the maintenance of Core Product Information (CPI) and US/EU Market Product information (MPI) for assigned AstraZeneca marketed or pipeline products in the Respiratory and Immunology (R&I) Therapy Area. The individual has a key role in the labeling group by sharing knowledge, line management/mentoring peers, and advising the R&I Labeling Senior Director to ensure appropriate project and resource planning.

ESSENTIAL REQUIREMENTS:

• Bachelor’s degree in Science or related discipline
• At least 5 years of pharmaceutical experience, including regulatory experience, preferably working with labeling
• Knowledge of labeling regulations and guidances
• 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

PREFERRED QUALIFICATIONS

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

• 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.
• Leads the development of the labeling strategy, in line with the overall regulatory strategy for the product and/or the disease area, 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 Product Labeling Team (PLT) in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents, US Prescribing Information, and Instructions For Use through to Senior Leader approval with the aim of achieving advantageous labeling.
• Leads the development of labeling negotiation strategies, anticipating health authority perspectives.
• Provides labeling expertise to the Regulatory teams and 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 propose 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.
• Is a visible, approachable leader and role model within and outside of Labeling teams.
• Coach or may lead a team of Labelling members, providing guidance and support to the individuals as required depending on their level of experience to ensure appropriate Labelling support across all allocated projects.