Associate Director, Labelling Strategy
Associate Director, Labelling Strategy
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Salary Not Disclosed
1 Vacancy
Job Description
At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledgesharing 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 facetoface 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 were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.
Introduction to role
Are you ready to lead the charge in regulatory labelling expertise for complex drug projects As a Labelling Strategy Associate Director you will be at the forefront of developing and implementing labelling strategies for AstraZenecas marketed and pipeline products. Collaborating with the Global Regulatory Submission Team and crossfunctional Product Labelling Teams you will ensure the maintenance of Core Product Information and Market Product Information for the US and EU. Your role will also involve mentoring peers and contributing to the growth of the labelling group. Are you prepared to make a significant impact
Accountabilities
- Ensure the labelling process is adhered to throughout the product lifecycle.
- Perform all tasks in compliance with established procedures regulatory requirements and GxPs.
- Lead the development of labelling strategies aligned with the overall regulatory strategy interpreting regulations and competitor analyses.
- Guide the preparation and maintenance of highquality Core Prescribing Information EU QRD US PI and IFUs through to Senior Leader approval.
- Develop labelling negotiation strategies anticipating Health Authority perspectives.
- Provide labelling expertise regarding language placement and regulatory content detail for CPI and MPI.
- Offer clarity on labelling requirements in complex situations including risk insight and proposing mitigations.
- Evaluate and communicate global regulations and trends on labelling and their business impact.
- Ensure effective communication across Labelling subfunctions.
- Justify and communicate labelling rationale to Senior Leaders for effective decisionmaking.
- Lead the development of target labelling documents as needed.
- Assist in developing 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
- Multicultural 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)
Great People want to Work with us! Find out why:
- GTAA Top Employer Award for 11 years
- Top 100 Employers Award
- Canadas Most Admired Corporate Culture
- Learn more about working with us in Canada
- View our YouTube channel
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.
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Date Posted
02May2025Closing Date
11May2025AstraZeneca 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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.
Required Experience:
Director
Employment Type
Full-Time
