Global Labeling Strategy Associate Director

hace 8 meses

Barcelona, España AstraZeneca A tiempo completo

Location: Barcelona

Join us at AstraZeneca, where we put patients first and strive to meet their unmet needs worldwide. We're looking for a productive, collaborative and confident labeling strategist to join our Vaccines and Immune Therapies (V&I) group. Here, we're pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. As a Labeling Strategy Associate Director (LSAD), you'll be responsible for the development and implementation of the global labeling strategies for assigned developmental and commercialized products within the V&I portfolio.

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 using our expertise in virology, microbiology and vaccines to enable novel approaches to prevent and treat infectious disease. We offer an outstanding and strong collaborative network as part of the AstraZeneca family, as together we explore alliances 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.

**What you’ll do**:

- Own the development of the labeling strategy by interpreting regulations, mentorship 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
- Lead the Product Labeling 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
- Provide labeling 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 labeling regulations and guidance
- Lead the development of labelling negotiation strategies, anticipating HA perspectives
- Provide clarity regarding applicable labeling requirements, expectations, risks and mitigations for complex situations to relevant stakeholders
- Evaluate, interpret and communicate global regulations and trends on labeling and any business impact these might have on product labeling
- Develop and communicate the rationale for labeling strategies to Senior Leaders to enable effective decision making
- Lead the development of target product labelling documents
- Contribute to the development of the labeling group by sharing knowledge and mentoring peers
- Assist in the development of labeling policies, procedures and SOPs

**Education, Qualifications, Skills and Experience**

**Essential**
- Bachelor’s degree in a science or related field
- Significant experience, including regulatory experience, in the pharmaceutical industry or at a health authority, preferably working with labeling
- Knowledge of labeling regulations and guidance
- 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 handle risk.
- Demonstrate competencies in building relationships, interpersonal awareness, critical information seeking, rational persuasion and negotiations skills.

**Desirable**
- Experience in labeling development or maintenance for vaccines or other antibacterial/antiviral products
- Advanced academic degree (PharmD, PhD) or specialized training

At AstraZeneca, we're not just about developing groundbreaking drugs. We're about turning our drug development strategies into reality. We're about thinking broadly about patients and what it takes to prevent and treat diseases. We're about being part of the solution, involved in key discussions, acting as both a drug developer and Regulator. We're about innovation at our heart, championing a new approach for Regulatory. We're about being a diverse and open-minded team harnessing our different skills and experiences. And most importantly, we're about bringing life-changing medicines to patients.

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