Global Labelling Strategy Manager

5 months ago

Mississauga, Canada AstraZeneca Full time

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 utilising our expertise in virology, microbiology, and vaccines to enable novel approaches to prevent and treat infectious disease. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies 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.

**About the role**:
The Labelling Strategy Manger is responsible for the development and implementation of the global labelling strategies for assigned developmental and commercialised products within the V&I portfolio. The Labelling Strategy Manager applies knowledge of global and local labelling requirements and trends to ensure that essential information regarding the safe and effective use of our products is available to healthcare professionals and patients.

**What you will do**:

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

**Must haves**:

- Bachelor’s degree (or equivalent) in a science or related discipline
- Relevant pharmaceutical experience, including regulatory experience
- 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 manage risk
- Demonstrate competencies in building relationships, interpersonal awareness, critical information seeking, rational persuasion and negotiations skills

**Desirable skills & experience**:

- Knowledge of labelling regulations and guidance
- Experience in labelling development and/or maintenance, including for vaccines or other antibacterial/antiviral products
- Advanced academic degree (PharmD, PhD) or specialized training

Great People want to Work with us Find out why:

- GTAA Top Employer Award for 10 years
- Top 100 Employers Award
- Canada’s Most Admired Corporate Culture
- Learn more about working with us in Canada
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