Associate Regulatory Affairs Director, Digital Projects

• Develop and implementdigitalAIand automation solutions to support the Regulatory Affairs digitalobjectivescontribute to enterprise regulatory digitalizationand enhance performancein coordination with business leaders

• Collaborate with internal stakeholders (e.g.ITDataProcess Change Management and vendors) to ensureavailability of key data and technologies necessary to support digital projects and to support enterprise-wide improvement initiatives

• Support digital and AI capability development across our team of Regulatory professionalsthrough leading training sessions and creating other educational resources to promote skill development among non-technical staff

• Define track andmonitorperformance metrics and KPIstoprioritize andmeasure the effectiveness of digitalprojectsacross regulatory affairs

• Communicate outcomes of digital projects to business leaders and other internal stakeholders to ensure successful delivery and positive return on investment

• Maintain awareness ofcurrent and future digital trendsin data analyticsPharmaor other relevant industries topromote continual growth in skills andexpertiserelated to AI and automation

Minimum Qualifications:

• 7 years of experience with Bachelors degree or higher in a sciencesocial sciencebusinessor information sciences discipline and/or relevant experience in the bio-pharmaceutical industry

• Biopharmaceutical industry experience withdemonstratedability toleveragedata and analytics for decision making

• Proven technical competence in developing and deploying solutions in support of data and information management(e.g. reports/dashboards data analyses curated datasets)

• Experience using Generative AI tools to perform day-to-day work tasks including prompt and/or context engineering and understanding of key limitations and design considerations such as human-in-the-loop

• Experienceutilizinga wide range of tools and technologies to deliver tangible AI and automation prototypes and operational solutions including low/no code AI and automation platforms occasional custom scripting (e.g. PythonVBA SQL) and business productivity software (e.g. Microsoft Office)

• Expertiseinstatistical analysis and performance measurement includingquantifying return on investment

• Proficient in strategic thinking creative problem solvingand excellent oral and written communication skills.

• Experiencewithregulatory drug development or equivalentorexperience with major Health Authorities including anunderstanding of guiding principles in drug developmentandtheUS and/or European regulatory ecosystems

• Experience working cross-functionally with diverse stakeholders including both technical staff (e.g. IT data governance) and non-technical staff (medical and scientific experts)

Desirable Qualifications:

• Moderate or higher skill in computer programming such as Python VBA or SQL includingproject experience using at least one of these programming languages

• Experience developing agentic AIworkflowsconnected to data or othercontent

• Experience working with commonly used Regulatory Affairs datasets or systems including RIM platforms and Health Authority datasets

• Knowledge of advanced analytics and machine learningincluding validationand cross-validationapproaches natural language processingneural network architectures or similar

• Solid understanding of the commercial aspects ofBiopharmaceuticaldevelopment

• Knowledge of the R&I therapeutic areaand abroad understanding of regulatory and drug development activities

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 ambitious - 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 meanswereopening new ways to work groundbreaking methods and bringing unexpected teams together. Interested Come and join our journey.

Sowhatsnext

Are you ready to bring new insights and fresh thinking to the table Brilliant! We have one seat available and we hopeitsyours.

The annual base pay (or hourly rate of compensation) for this position ranges from 135624.80 - 203437.20 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) to receive a retirement contribution (hourly roles) and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.