Join us at AstraZeneca, where we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. Our exceptional team is working on the groundbreaking area of cellular therapies, and we are investing in internal capabilities to discover and accelerate the delivery of next-generation cellular therapies for patients. As part of our Regulatory Labelling team, you will play a crucial role in bringing these transformative therapies from the lab to life.

We are now recruiting a Global Labeling Strategy Director to provide regulatory labeling expertise and guidance in this Immunology Cell Therapy area. In this role you will lead and contribute to developing and crafting the strategic direction of the labeling component of the regulatory strategy for these cell therapy products, along with developing and maintaining the Core Product Information (CPI) and US/EU Market Product information (MPI)

This opportunity is available at our Boston Seaport, MA (USA) location.

We expect employees to be on-site for a minimum of 3 days per week.

What You'll Do:

Ensures that the labeling process is followed through the lifecycle of the product.
Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
Leads the development of the labeling strategy, in line with the overall regulatory strategy for the product and/or the disease area, 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.
Leads the Product Labeling Team (PLT) in the preparation and maintenance of high-quality Core Prescribing Information (CPI), EU Quality Review of Documents (QRD), US Prescribing Information (US PI) , and Instructions For Use (IFU) through to Senior Leader approval with the aim of achieving advantageous labeling.
Leads the development of labeling negotiation strategies, anticipating health authority perspectives.
Provides labeling expertise to the Regulatory teams and PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labeling regulations and guidance.
Provides clarity regarding applicable labeling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations.
Evaluates, interprets and communicates global regulations and trends on labeling and any business impact these might have on product labeling.
Able to justify and communicate the labeling rationale to Senior Leaders to enable effective decision-making.
Develop labeling documents, policies, procedures and SOPs.
Is a visible, approachable leader and role model within and outside of Labeling 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.

Essential Requirements:

Bachelor's degree in Science or related discipline
At least 5 years of pharmaceutical experience, including regulatory experience, preferably working with labeling in Immunology Cell Therapy
Knowledge of labeling 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)

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting-edge methods and bringing unexpected teams together. Come and join our journey.

So, what's next!

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026. Find out more information here: Kendall Square Press Release

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a phenomenal fit, please share this posting with them.

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.

Date Posted

08-Aug-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.