Associate Director, Labelling Strategy

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.

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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 AstraZeneca's marketed and pipeline products. Collaborating with the Global Regulatory Submission Team and cross-functional 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 high-quality 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 decision-making.
• 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
• Multi-cultural 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)

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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 AZCHumanResources@astrazeneca.com.

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AstraZeneca 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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.