Regulatory Affairs Strategy Director

Director Regulatory Affairs Strategy

Job Description

Are you passionate about scienceandexperienced within regulatory affairs and drug development Do youpossessstrategic and operational leadership skillsThen join us atCardiovascular Renalor Metabolism (CVRM) regulatory affairsto get involved in the global regulatory strategies and support the researchdevelopmentand commercialization of our products across the portfolio!

About AstraZeneca

At AstraZeneca we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial thinking big and working together to make the impossible a reality. If you are swift to action confident to lead willing to collaborate and curious about what science can do thenyoureour kind of person.

Cardiovascular Renal & Metabolism - Regulatory Science and Strategy

AstraZenecas pipeline of innovative medicines is consistently growing within Cardiovascular Renal & Metabolism (CVRM). To meet the increasing demand of regulatoryexpertise we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists. With us you will get the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline of both small and big molecules. You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the developmentcommercializationand life cycle management of assigned products. Serves as the global regulatory lead (GRL) on projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

Whatyoulldo

As a Regulatory Affairs professional within AstraZeneca you will play a key role inchannellingour scientific capabilities to make a positive impact on changing patients Regulatory Affairs our teams influence the development of our innovative pipeline define the regulatory strategy for our therapeutic assets and engage with Health Authorities to effectively inform our development this way our Regulatory Affairs teams are transforming exciting science into valued new medicines for patients around the world. Strategic thinking is key within our function. The more experienced you are the more accountability you will have for strategic leadership including responsibility for development and implementation of the global regulatory strategy for a product/group of products of increasing complexity.

Essentialfor theRole:

• AdvancedDegree in Life Science or related discipline.

• 5 years of proven experience defining and implementing the regulatory strategy for a pharmaceutical organization.

• Extensive knowledge of regulatory affairs within one or more therapeutic areas in early and late development

• Proventrack recordof regulatory drug development including product approval/launch.

• Experience in leading Major Health Authority interactions

• Ability to think strategically and critically and evaluate risks to regulatory activities.

• Ability to work strategically within a complex business critical and high-profile development program.

Why AstraZeneca

At AstraZenecawerededicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit.Theresno better place to make a difference to medicinepatientsand society. An inclusive culture that champions diversity and collaboration and always committed to lifelong learninggrowthand development.Wereon an exciting journey to pioneer the future of healthcare.

Competitive salary and benefits package on offer:

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.

The annual base salary for this position ranges from $186232.80 - 279349.20. However 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 toparticipatein our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly 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 coveragein accordance withthe terms and conditions of the applicable plans.Additionaldetails 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 salary (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.