Labelling Strategy Director

Mississauga, ON
Permanent
Full-time

14 days ago

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.Are you experienced within Regulatory Affairs and Labelling? Do you have a strong scientific background and are able to assimilate clinical and scientific information and present it in a concise manner? Then, join us at the Respiratory and Immunology (R&I) Regulatory Labelling Strategy team to get involved in shaping global regulatory labelling strategies and support the research, development and commercialisation of our R&I products across the portfolio.AstraZeneca’s pipeline of innovative medicines is consistently growing and within the R&I Regulatory Labelling Strategy team we take innovative labelling approaches to bring these R&I life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently as possible. As an industry leading R&I Regulatory function, we’re focused and committed to the development of our products as well as to our people – providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.The Role:We are seeking a new member to join the team in the role of Labelling Strategy Director, the role will be located in Mississauga, Canada.What You’ll Do:Working in the role as Labelling Strategy Director, you will provide regulatory strategic labelling expertise and guidance, 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 role leads the development/implementation of the labelling strategy and maintenance of Core Product Information (CPI) and United States (US) / European Union (EU) Market Product information (MPI) for assigned marketed or pipeline products in the R&I therapy area. The individual has a key role in the development of the labelling group by sharing knowledge and mentoring peers and supports and advises the respective Senior Director Group Manager (SDGM) to ensure appropriate project and resource planning. The Labelling Strategy Director will coach or may serve as a line manager for Labelling members in the group and in conjunction with SDGM will be involved in hiring, training, coaching, and career development of staff.Your main accountabilities/responsibilities:

Lead the development of the labelling strategy, in line with the overall regulatory strategy for the product, 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.
Lead the PLT in the preparation and maintenance of high-quality Core Product Information, EU Quality Review of Documents (QRD), US Prescribing Information (PI), and Instructions for Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
Lead the development of labelling negotiation strategies, anticipating health authority perspectives.
Provide 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.
Provide clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations.
Evaluate, interpret and communicate global regulations and trends on labelling and any business impact these might have on product labelling.
Lead the development of Target Product Labelling (TPL) documents
Assist in the development of labelling documents, policies, procedures and SOPs.
Ensure 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.
Is a visible, approachable leader and role model within and outside of Labelling 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.
Effectively deputise for the SDGM as required.

Essential Experience/Skills:

University Degree in Science or related discipline
3 to 5 years of pharmaceutical experience, including regulatory and labelling experience
Ability to assimilate clinical and scientific information and present it in a concise manner
Knowledge of labelling 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
Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures
Must demonstrate competencies in building relationships, negotiation skills, critical information seeking, rational persuasion, interpersonal awareness

Preferred:

Advanced academic training is highly desirable (PharmD, PhD)

Great People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .#LI-HybridWe are using AI as part of the recruitment process.This advertisement relates to a current vacancy.

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